Chronic Low-back PainNCT05690178
Deep Tissue Massage in Office Workers With Chronic Low Back Pain
A study testing Deep Tissue Massage in people with Chronic Low-back Pain, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The main objective of the study was to assess the impact of deep tissue massage on subjective and objective parameters in a group of office workers with chronic low back pain. Specific objectives: Assessment of the impact of deep tissue massage on the level of pain Assessment of the impact of deep tissue massage on… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Deep Tissue Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic Low-Back Pain
- office worker
Who cannot join
- spine surgeries
- cauda equina syndrome
- cancer
- pain or motor and sensory deficits in the lower extremities below the level of the knee
- various therapies to treat chronic low-back pain
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education, Department of Biology and Anatomy
Poznan, Wielkopolska, 61-871
About this study
Official title: Effect of Deep Tissue Massage on Subjective and Objective Parameters in Office Workers With Chronic Low Back Pain
The main objective of the study was to assess the impact of deep tissue massage on subjective and objective parameters in a group of office workers with chronic low back pain.
Specific objectives:
Read more
- Assessment of the impact of deep tissue massage on the level of pain
- Assessment of the impact of deep tissue massage on the level of disability
- Assessment of the impact of deep tissue massage on the mobility of the lumbar spine
- Assessment of the effect of deep tissue massage on the discomfort threshold of tissue compression in the area of the erector spinae muscle
- Assessment of the impact of deep tissue massage on the biophysical parameters of the soft tissues of the erector spinae muscle
- Evaluation of the impact of deep tissue massage on the bioelectric potentials of the erector spinae muscle during everyday activities and the flexion-relaxation test
Hypotheses:
- Deep tissue massage will reduce the level of pain in the lumbar spine
- Deep tissue massage will reduce the level of disability
- Deep tissue massage will increase the range of motion of the lumbar spine in all directions
- Deep tissue massage will reduce the threshold of discomfort when compressing the soft tissues of the erector spinae muscle
- Deep tissue massage will reduce muscle tone and stiffness and increase the elasticity of the back extensor muscle
- Deep tissue massage will increase the bioelectrical potentials of the erector spinae muscle while performing tests of activities of daily living
- Deep tissue massage will reduce the value of the flexion-relaxation test
Read the detailed description
Deep tissue massage is a manual action of the therapist in the superficial and deep layers of muscles and fascia in order to relax, change abnormal patterns, eliminate tension and pain in a maximally ergonomic way. Deep tissue massage should be described as an independent method of therapy using a specific set of techniques and principles. It is a safe method with a wide range of applications, while the techniques themselves can be modified to the needs of the patient. It is believed that deep tissue massage causes: improvement of tissue blood supply, reduction of muscle tension, stretching of muscles and fascia, improvement of muscle and joint function.
Participants A total of 40 patients (30 to 60 years of age) participated in the study. All participants were characterized by the presence of chronic low back pain syndrome, performed office work for 8 hours a day and were characterized by moderate physical activity. Using randomization, participants were divided into two groups (experimental and control). The experimental group included participants who received deep tissue massage (N=20, 18 women and 2 men, average age: 40). The control group included participants who did not receive therapy (N=20, 13 women and 7 men, average age: 43).
Intervention The deep tissue massage lasted 45 minutes. The entire therapy included 4 treatments over a period of 2 weeks. The interval between treatments was 3 days. The conducted therapy included techniques for: quadratus lumborum muscle, erector spinae muscle, thoracolumbar fascia, iliopsoas muscle. All techniques were performed on both sides of the patient's body.
Research methods
The following measurement equipment was used to collect the data:
- Electrogoniometer. Penny \& Giles strain gauge electrogoniometer with two sensors (SG150 - two-axis, Q110 - single-axis). Measurements were taken in a standing position, in accordance with the measurement methodology according to Lewandowsky. All movements of the lumbar spine (forward bending, backward bending, right bending, left bending, right rotation, left rotation) were examined. The average of the three measurements was the result of movability for a given direction. The sensors were attached to the skin using Biometrics double-sided tape. The upper sensor was placed on the Th12 spinous process (lower edge of the sensor), while the lower sensor was mounted on the base of the sacrum (upper edge).
- Algometer. The Wagner Instruments algometer was used to assess the subjective parameter, i.e. the first discomfort threshold. In the study, the measurement site was the point located on the longissimus muscle, which is a component of the erector spinae muscle. The subjects lay in front. The pressure, detected by the algometer sensor, was applied from above and perpendicularly to the examined muscle (two fingers laterally from the L1 spinous process). Three measurements were made alternately for both sides of the examined muscle. From these measurements, mean values were calculated, which were the results for the right and left sides of the examined muscle.
- MyotonPRO. In order to study the biophysical parameters of soft tissues, i.e. muscle tone (F) [Hz], stiffness (S) [N/m] and elasticity (D) [no units], the MyotonPRO apparatus was used. During the measurements, the tested person lay on his front. Measurements were made on the longissimus muscle (2 fingers lateral to the L1 spinous process). The pattern composer was programmed as follows: tapping time: 15 ms, interval: 0.8 s, mode: multiscan (5 repetitions). Measurements were made on the right and left muscles.
- Kinesiologic electromyography (EMG). Kinesiologic electromyography was carried out with an 8-channel electromyographic system with plate electrodes (model W4X8, Biometrics Ltd). The results were recorded using DataLog Bluetooth V7.5 software (Biometrics Ltd). During the examination, six multiple-use surface electrodes (type SX230 1000) were attached with an adhesive tape, after removal of body hair froma 2 cm x 1 cm area of intact skin, disinfection of electrode surface, and wiping the skin a few times with salicylic alcohol to reduce its resistance. The reference electrode (type R230, Biometrics Ltd) was fixed at the distal end of the radius (Lister's tubercle region) with an elastic band. The examination involved lumbar segment of the longissimus muscle, iliocostalis and multifidus (both right- and left-sided bundles). The electrodes were placed according to the international guidelines published by SENIAM. The examination was painless and noninvasive and did not require subject's exposure to any additional electric stimulation. The measurement was preceded by a 10-min warm-up of the keymuscle groups. The list of determined electromyographic parameters included the amplitude of bioelectrical signal from the longissimus, iliocostalis and multifidus muscles, expressed in microvolt. Avoiding a confounding effect associated with measurement conditions, the results were normalized to a reference Maximum Voluntary Contraction (MVC) and expressed in percent. After fixation of the electrodes and preparation of the system, MVC of the longissimus, iliocostalis and multifidus were determined according to the international SENIAM guidelines. The examination started with the subject lying down in a prone position, with arms crossed under the chin, and extended legs. The EMG recordings were obtained during three active extensions of the spine, each lasting 3 seconds, with 30-second intervals in between. MVCs , corresponding to 100% neuromuscular activation of the muscles, was calculated as the mean amplitude for the three repetitions (for each muscle). At the beginning, the Flexion-Relaxation (FR) test was performed. The participant performed forward flexion of the spine and hung freely in this position for 10 seconds. During this test, the participant was asked to be as relaxed as possible. Then the participant was tested during successive tests of activities of daily living: getting up from a chair, sitting on it, lifting and lowering a 1 kg and 2 kg weight. Each test was run at an individually adjusted pace and consisted of three repetitions with 30-second rests between them. The test started at the investigator's request. While lifting and lowering the weights, the subjects kept a straight back, and each hold of the weight lasted 3 seconds and was performed on straight elbows. The result of each test is presented as the mean amplitude for three repetitions for each muscle. The results were normalized to the MVC to assess the degree of muscle involvement during various activities (standing up, sitting down, raising and lowering the roller) in relation to maximal neuromuscular activation. To ensure accurate results, the correct attachment of each electrode was rechecked before each repetition.
- Revised Oswestry Pain Questionnaire (ODI). The degree of LBP imposed limitations in activity of daily ling (ADLs) was determined with Revised Oswestry Pain Questionnaire, also referred to as Oswestry Disability Index (ODI). The survey consisted of 10 questions, each with 6 possible responses scored from 0 to 5 points. If the respondent chose more than one answer to a given question, the one with higher score was recorded and subjected to the analysis. Maximum overall score amounted to 50 points, which corresponded to 100% disability due to lumbar pain.
- Roland-Morris Disability Questionnaire (RMDQ). The instrument consists of 24 statements about pain and its influence on ADLs. The respondent chooses only the statements that refer to his/her ailments. Maximum overall score may vary between 0 and 24 points.
- Visual-Analog Scale (VAS). This subjective tool is used to assess the level of pain. The participant marks the level of pain on a 10 cm scale, where 0 is no pain and 10 is the maximum pain he has ever felt.
In order to assess the impact of deep tissue massage therapy on the study population, two measurements were made over time: before and after therapy.
Ethics All measurement methods used were non-invasive and safe for health. The study was approved by the local Bioethics Committee. Each participant had the right to withdraw from the study at any stage. All collected data is anonymous and will be used only to conduct statistical analyzes for scientific purposes.
- Conditions
- Chronic Low-back Pain
- Being tested
- Deep Tissue Massage
- Keywords
- Chronic Low-back Pain, Range of motion, Pressure pain threshold, Myoton, Muscle properties, Surface electromyography, Oswestry Disability Index, Rolland Morris Disability Questionnaire, Disability, Visual Analogue Scale, Deep Tissue Massage, Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Tissue MassageOther
The Deep Tissue Massage lasted 45 minutes. The entire therapy included 4 treatments over a period of 2 weeks. The interval between treatments was 3 days. The conducted therapy included techniques for: quadratus lumborum muscle, erector spinae muscle, thoracolumbar fascia, iliopsoas muscle. All techniques were performed on both sides of the patient's body.
| Study group | Role | What they receive |
|---|---|---|
| DTM group | Experimental | This group of participants (N=20) received Deep Tissue Massage therapy. Receives: Other: Deep Tissue Massage |
| Control group | No intervention | This group of participants (N=20) did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar anterior flexion (PRE)
Electrogoniometric measurement of the angular range of motion the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar anterior flexion (POST)
Electrogoniometric measurement of the angular range of motion the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar posterior flexion (PRE)
Electrogoniometric measurement of the angular range of motion the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar posterior flexion (POST)
Electrogoniometric measurement of the angular range of motion the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar right flexion (PRE)
Electrogoniometric measurement of the angular range of motion the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar right flexion (POST)
Electrogoniometric measurement of the angular range of motion the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar left flexion (PRE)
Electrogoniometric measurement of the angular range of motion the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar left flexion (POST)
Electrogoniometric measurement of the angular range of motion the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar right rotation (PRE)
Electrogoniometric measurement of the angular range of motion the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar right rotation (POST)
Electrogoniometric measurement of the angular range of motion the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar left rotation (PRE)
Electrogoniometric measurement of the angular range of motion the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Lumbar left rotation (POST)
Electrogoniometric measurement of the angular range of motion the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Stiffness (S) of the right longissimus muscle (PRE)
Myotonometer examination of soft tissue properties the day before the intervention
Measured: Through study completion, an average of 2 weeks.
Stiffness (S) of the right longissimus muscle (POST)
Myotonometer examination of soft tissue properties the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Stiffness (S) of the left longissimus muscle (PRE)
Myotonometer examination of soft tissue properties the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Stiffness (S) of the left longissimus muscle (POST)
Myotonometer examination of soft tissue properties the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Elasticity (D) of the right longissimus muscle (PRE)
Myotonometer examination of soft tissue properties the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Elasticity (D) of the right longissimus muscle (POST)
Myotonometer examination of soft tissue properties the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Elasticity (D) of the left longissimus muscle (PRE)
Myotonometer examination of soft tissue properties the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Elasticity (D) of the left longissimus muscle (POST)
Myotonometer examination of soft tissue properties the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Muscle tone (F) of the right longissimus muscle (PRE)
Myotonometer examination of soft tissue properties the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Muscle tone (F) of the right longissimus muscle (POST)
Myotonometer examination of soft tissue properties the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Muscle tone (F) of the left longissimus muscle (PRE)
Myotonometer examination of soft tissue properties the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Muscle tone (F) of the left longissimus muscle (POST)
Myotonometer examination of soft tissue properties the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Pressure pain threshold (PPT) of the right longissimus muscle (PRE)
Examination of the first discomfort threshold using an algometer the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Pressure pain threshold (PPT) of the right longissimus muscle (POST)
Examination of the first discomfort threshold using an algometer the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Pressure pain threshold (PPT) of the left longissimus muscle (PRE)
Examination of the first discomfort threshold using an algometer the day before the therapy
Measured: Through study completion, an average of 2 weeks.
Pressure pain threshold (PPT) of the left longissimus muscle (POST)
Examination of the first discomfort threshold using an algometer the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for right longissimus muscle (PRE)
Electromyographic measurements of maximal voluntary contraction of the right longissimus muscle the day before therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for right longissimus muscle (POST)
Electromyographic measurements of maximal voluntary contraction of the right longissimus muscle the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for left longissimus muscle (PRE)
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for left longissimus muscle (POST)
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for right iliocostalis muscle (PRE)
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for right iliocostalis muscle (POST)
Electromyographic measurements of maximal voluntary contraction of the right iliocostalis muscle the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for left iliocostalis muscle (PRE)
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for left iliocostalis muscle (POST)
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for right multifidus muscle (PRE)
Electromyographic measurements of maximal voluntary contraction of the right multifidus muscle the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for right multifidus muscle (POST)
Electromyographic measurements of maximal voluntary contraction of the right multifidus muscle the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for left multifidus muscle (PRE)
Electromyographic measurements of maximal voluntary contraction of the left multifidus muscle the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - MVC for left multifidus muscle (POST)
Electromyographic measurements of maximal voluntary contraction of the left multifidus muscle the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for right longissimus muscle (PRE)
Electromyographic measurements of the right longissimus muscle during the Flexion-Relaxation test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for right longissimus muscle (POST)
Electromyographic measurements of the right longissimus muscle during the Flexion-Relaxation test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for left longissimus muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for left longissimus muscle (POST)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for right iliocostalis muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for right iliocostalis muscle (POST)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for left iliocostalis muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for left iliocostalis muscle (POST)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for right multifidus muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for right multifidus muscle (POST)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for left multifidus muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - FR test for left multifidus muscle (POST)
Electromyographic measurements of the left multifidus muscle during the Flexion-Relaxation test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for right longissimus muscle (PRE)
Electromyographic measurements of the left multifidus muscle during sitting and standing test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for right longissimus muscle (POST)
Electromyographic measurements of the right longissimus muscle during sitting and standing test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for left longissimus muscle (PRE)
Electromyographic measurements of the left longissimus muscle during sitting and standing test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for left longissimus muscle (POST)
Electromyographic measurements of the left longissimus muscle during sitting and standing test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for right iliocostalis muscle (PRE)
Electromyographic measurements of the right iliocostalis muscle during sitting and standing test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for right iliocostalis muscle (POST)
Electromyographic measurements of the right iliocostalis muscle during sitting and standing test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for left iliocostalis muscle (PRE)
Electromyographic measurements of the left iliocostalis muscle during sitting and standing test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for left iliocostalis muscle (POST)
Electromyographic measurements of the left iliocostalis muscle during sitting and standing test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for right multifidus muscle (PRE)
Electromyographic measurements of the right multifidus muscle during sitting and standing test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for right multifidus muscle (POST)
Electromyographic measurements of the right multifidus muscle during sitting and standing test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for left multifidus muscle (PRE)
Electromyographic measurements of the left multifidus muscle during sitting and standing test the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - sitting and standing test for left multifidus muscle (POST)
Electromyographic measurements of the left multifidus muscle during sitting and standing test the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for right longissimus muscle (PRE)
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for right longissimus muscle (POST)
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for left longissimus muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for left longissimus muscle (POST)
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for right iliocostalis muscle (PRE)
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for right iliocostalis muscle (POST)
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for left iliocostalis muscle (PRE)
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for left iliocostalis muscle (POST)
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for right multifidus muscle (PRE)
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for right multifidus muscle (POST)
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for left multifidus muscle (PRE)
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (1 kg) for left multifidus muscle (POST)
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for right longissimus muscle (PRE)
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for right longissimus muscle (POST)
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for left longissimus muscle (PRE)
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for left longissimus muscle (POST)
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for right iliocostalis muscle (PRE)
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for right iliocostalis muscle (POST)
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for left iliocostalis muscle (PRE)
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for left iliocostalis muscle (POST)
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for right multifidus muscle (PRE)
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for right multifidus muscle (POST)
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for left multifidus muscle (PRE)
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day before the therapy
Measured: Through study completion, an average of 2 weeks.
EMG - weight holding test (2 kg) for left multifidus muscle (POST)
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day after the therapy
Measured: Through study completion, an average of 2 weeks.
Revised Oswestry Pain Questionnaire (PRE)
Revised Oswestry Pain Questionnaire (ODI) - the day before therapy. The minimum score is 0, while the maximum is 50, which proves 100% disability. A higher result is worse and proves the patient's disability in everyday activities.
Measured: Through study completion, an average of 2 weeks.
Revised Oswestry Pain Questionnaire (POST)
Revised Oswestry Pain Questionnaire (ODI) - the day after therapy. The minimum score is 0, while the maximum is 50, which proves 100% disability. A higher result is worse and proves the patient's disability in everyday activities.
Measured: Through study completion, an average of 2 weeks.
Roland-Morris Disability Questionnaire (PRE)
Roland-Morris Disability Questionnaire (RMDQ) - the day before therapy. The minimum score is 0, while the maximum is 24. The higher the score, the worse it is and it illustrates the poor functional condition of the examined person.
Measured: Through study completion, an average of 2 weeks.
Roland-Morris Disability Questionnaire (POST)
Roland-Morris Disability Questionnaire (RMDQ) - the day after therapy. The minimum score is 0, while the maximum is 24. The higher the score, the worse it is and it illustrates the poor functional condition of the examined person.
Measured: Through study completion, an average of 2 weeks.
Visual-Analog Scale (PRE)
Visual-Analog Scale (VAS) - the day before therapy. The minimum score is 0 and the maximum score is 10. The higher the score, the worse it is and it reflects the subjective level of pain experienced.
Measured: Through study completion, an average of 2 weeks.
Visual-Analog Scale (POST)
Visual-Analog Scale (VAS) - the day after therapy. The minimum score is 0 and the maximum score is 10. The higher the score, the worse it is and it reflects the subjective level of pain experienced.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Sep 2021
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first step was recruitment. Based on the qualifying and disqualifying criteria, 40 people were selected. Each participant was randomly assigned to a specific group (Deep Tissue Massage (DTM) experimental group or control group). Initial measurements were collected from all participants. Participants in the DTM group had therapy, while those in the control group had no therapy. The therapist was responsible for performing the DTM therapy. Each participant in the experimental group received 4 treatments (45 minutes each, 3 days between them) over a period of 2 weeks. After the end of the whole therapy, final measurements were made. The researcher was responsible for taking measurements for each participant. The person acting as the coordinator supervised the proper course of the research. The collected data was analyzed by a person evaluating the results.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Wendt, Poznan University of Physical Education
- Investigators
- Michał Wendt, PhD, Principal investigator, Poznan University of Physical Education, Department of Biology and Anatomy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690178
- Sponsor's protocol ID
- DTM-CLBP-OW
- Status last verified
- Aug 2023
- First submitted
- 1 Jan 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: University IPD sharing platform is under preparation. All data will also be available to researchers via the principal researcher's email (wendt@awf.poznan.pl) or Research Gate website.
Publications
Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
PubMed 22630613Williams ACC, Craig KD. Updating the definition of pain. Pain. 2016 Nov;157(11):2420-2423. doi: 10.1097/j.pain.0000000000000613. No abstract available.
PubMed 27200490Schuenke MD, Vleeming A, Van Hoof T, Willard FH. A description of the lumbar interfascial triangle and its relation with the lateral raphe: anatomical constituents of load transfer through the lateral margin of the thoracolumbar fascia. J Anat. 2012 Dec;221(6):568-76. doi: 10.1111/j.1469-7580.2012.01517.x. Epub 2012 May 15.
PubMed 22582887Tesarz J, Hoheisel U, Wiedenhofer B, Mense S. Sensory innervation of the thoracolumbar fascia in rats and humans. Neuroscience. 2011 Oct 27;194:302-8. doi: 10.1016/j.neuroscience.2011.07.066. Epub 2011 Aug 2.
PubMed 21839150Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
PubMed 28631003Nakipoglu GF, Karagoz A, Ozgirgin N. The biomechanics of the lumbosacral region in acute and chronic low back pain patients. Pain Physician. 2008 Jul-Aug;11(4):505-11.
PubMed 18690279Marshall PWM, Schabrun S, Knox MF. Physical activity and the mediating effect of fear, depression, anxiety, and catastrophizing on pain related disability in people with chronic low back pain. PLoS One. 2017 Jul 7;12(7):e0180788. doi: 10.1371/journal.pone.0180788. eCollection 2017.
PubMed 28686644Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PubMed 27745712Le Huec JC, Thompson W, Mohsinaly Y, Barrey C, Faundez A. Sagittal balance of the spine. Eur Spine J. 2019 Sep;28(9):1889-1905. doi: 10.1007/s00586-019-06083-1. Epub 2019 Jul 22.
PubMed 31332569Koren Y, Kalichman L. Deep tissue massage: What are we talking about? J Bodyw Mov Ther. 2018 Apr;22(2):247-251. doi: 10.1016/j.jbmt.2017.05.006. Epub 2017 May 17.
PubMed 29861215Cai XY, Sun MS, Huang YP, Liu ZX, Liu CJ, Du CF, Yang Q. Biomechanical Effect of L4 -L5 Intervertebral Disc Degeneration on the Lower Lumbar Spine: A Finite Element Study. Orthop Surg. 2020 Jun;12(3):917-930. doi: 10.1111/os.12703. Epub 2020 May 31.
PubMed 32476282Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.
PubMed 19762151Hansen AE, Marcus NJ. Is It Time to Consider Soft Tissue as a Pain Generator in Nonspecific Low Back Pain? Pain Med. 2016 Nov;17(11):1969-1970. doi: 10.1093/pm/pnw204. Epub 2016 Aug 27. No abstract available.
PubMed 27570247Zheng Z, Wang J, Gao Q, Hou J, Ma L, Jiang C, Chen G. Therapeutic evaluation of lumbar tender point deep massage for chronic non-specific low back pain. J Tradit Chin Med. 2012 Dec;32(4):534-7. doi: 10.1016/s0254-6272(13)60066-7.
PubMed 23427384Majchrzycki M, Kocur P, Kotwicki T. Deep tissue massage and nonsteroidal anti-inflammatory drugs for low back pain: a prospective randomized trial. ScientificWorldJournal. 2014 Feb 23;2014:287597. doi: 10.1155/2014/287597. eCollection 2014.
PubMed 24707200
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Tissue Massage on Subjective and Objective Parameters in Office Workers With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05690178
- Acronym / sponsor ID
- DTM-CLBP-OW
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low-back Pain, Range of motion, Pressure pain threshold, Myoton, Muscle properties, Surface electromyography, Oswestry Disability Index, Rolland Morris Disability Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study was to assess the impact of deep tissue massage on subjective and objective parameters in a group of office workers with chronic low back pain.
Specific objectives:
- Assessment of the impact of deep tissue massage on the level of pain
- Assessment of the impact of deep tissue massage on the level of disability
- Assessment of the impact of deep tissue massage on the mobility of the lumbar spine
- Assessment of the effect of deep tissue massage on the discomfort threshold of tissue compression in the area of the erector spinae muscle
- Assessment of the impact of deep tissue massage on the biophysical parameters of the soft tissues of the erector spinae muscle
- Evaluation of the impact of deep tissue massage on the bioelectric potentials of the erector spinae muscle during everyday activities and the flexion-relaxation test
Hypotheses:
- Deep tissue massage will reduce the level of pain in the lumbar spine
- Deep tissue massage will reduce the level of disability
- Deep tissue massage will increase the range of motion of the lumbar spine in all directions
- Deep tissue massage will reduce the threshold of discomfort when compressing the soft tissues of the erector spinae muscle
- Deep tissue massage will reduce muscle tone and stiffness and increase the elasticity of the back extensor muscle
- Deep tissue massage will increase the bioelectrical potentials of the erector spinae muscle while performing tests of activities of daily living
- Deep tissue massage will reduce the value of the flexion-relaxation test
Detailed description
Deep tissue massage is a manual action of the therapist in the superficial and deep layers of muscles and fascia in order to relax, change abnormal patterns, eliminate tension and pain in a maximally ergonomic way. Deep tissue massage should be described as an independent method of therapy using a specific set of techniques and principles. It is a safe method with a wide range of applications, while the techniques themselves can be modified to the needs of the patient. It is believed that deep tissue massage causes: improvement of tissue blood supply, reduction of muscle tension, stretching of muscles and fascia, improvement of muscle and joint function.
Participants A total of 40 patients (30 to 60 years of age) participated in the study. All participants were characterized by the presence of chronic low back pain syndrome, performed office work for 8 hours a day and were characterized by moderate physical activity. Using randomization, participants were divided into two groups (experimental and control). The experimental group included participants who received deep tissue massage (N=20, 18 women and 2 men, average age: 40). The control group included participants who did not receive therapy (N=20, 13 women and 7 men, average age: 43).
Intervention The deep tissue massage lasted 45 minutes. The entire therapy included 4 treatments over a period of 2 weeks. The interval between treatments was 3 days. The conducted therapy included techniques for: quadratus lumborum muscle, erector spinae muscle, thoracolumbar fascia, iliopsoas muscle. All techniques were performed on both sides of the patient's body.
Research methods
The following measurement equipment was used to collect the data:
- Electrogoniometer. Penny \& Giles strain gauge electrogoniometer with two sensors (SG150 - two-axis, Q110 - single-axis). Measurements were taken in a standing position, in accordance with the measurement methodology according to Lewandowsky. All movements of the lumbar spine (forward bending, backward bending, right bending, left bending, right rotation, left rotation) were examined. The average of the three measurements was the result of movability for a given direction. The sensors were attached to the skin using Biometrics double-sided tape. The upper sensor was placed on the Th12 spinous process (lower edge of the sensor), while the lower sensor was mounted on the base of the sacrum (upper edge).
- Algometer. The Wagner Instruments algometer was used to assess the subjective parameter, i.e. the first discomfort threshold. In the study, the measurement site was the point located on the longissimus muscle, which is a component of the erector spinae muscle. The subjects lay in front. The pressure, detected by the algometer sensor, was applied from above and perpendicularly to the examined muscle (two fingers laterally from the L1 spinous process). Three measurements were made alternately for both sides of the examined muscle. From these measurements, mean values were calculated, which were the results for the right and left sides of the examined muscle.
- MyotonPRO. In order to study the biophysical parameters of soft tissues, i.e. muscle tone (F) [Hz], stiffness (S) [N/m] and elasticity (D) [no units], the MyotonPRO apparatus was used. During the measurements, the tested person lay on his front. Measurements were made on the longissimus muscle (2 fingers lateral to the L1 spinous process). The pattern composer was programmed as follows: tapping time: 15 ms, interval: 0.8 s, mode: multiscan (5 repetitions). Measurements were made on the right and left muscles.
- Kinesiologic electromyography (EMG). Kinesiologic electromyography was carried out with an 8-channel electromyographic system with plate electrodes (model W4X8, Biometrics Ltd). The results were recorded using DataLog Bluetooth V7.5 software (Biometrics Ltd). During the examination, six multiple-use surface electrodes (type SX230 1000) were attached with an adhesive tape, after removal of body hair froma 2 cm x 1 cm area of intact skin, disinfection of electrode surface, and wiping the skin a few times with salicylic alcohol to reduce its resistance. The reference electrode (type R230, Biometrics Ltd) was fixed at the distal end of the radius (Lister's tubercle region) with an elastic band. The examination involved lumbar segment of the longissimus muscle, iliocostalis and multifidus (both right- and left-sided bundles). The electrodes were placed according to the international guidelines published by SENIAM. The examination was painless and noninvasive and did not require subject's exposure to any additional electric stimulation. The measurement was preceded by a 10-min warm-up of the keymuscle groups. The list of determined electromyographic parameters included the amplitude of bioelectrical signal from the longissimus, iliocostalis and multifidus muscles, expressed in microvolt. Avoiding a confounding effect associated with measurement conditions, the results were normalized to a reference Maximum Voluntary Contraction (MVC) and expressed in percent. After fixation of the electrodes and preparation of the system, MVC of the longissimus, iliocostalis and multifidus were determined according to the international SENIAM guidelines. The examination started with the subject lying down in a prone position, with arms crossed under the chin, and extended legs. The EMG recordings were obtained during three active extensions of the spine, each lasting 3 seconds, with 30-second intervals in between. MVCs , corresponding to 100% neuromuscular activation of the muscles, was calculated as the mean amplitude for the three repetitions (for each muscle). At the beginning, the Flexion-Relaxation (FR) test was performed. The participant performed forward flexion of the spine and hung freely in this position for 10 seconds. During this test, the participant was asked to be as relaxed as possible. Then the participant was tested during successive tests of activities of daily living: getting up from a chair, sitting on it, lifting and lowering a 1 kg and 2 kg weight. Each test was run at an individually adjusted pace and consisted of three repetitions with 30-second rests between them. The test started at the investigator's request. While lifting and lowering the weights, the subjects kept a straight back, and each hold of the weight lasted 3 seconds and was performed on straight elbows. The result of each test is presented as the mean amplitude for three repetitions for each muscle. The results were normalized to the MVC to assess the degree of muscle involvement during various activities (standing up, sitting down, raising and lowering the roller) in relation to maximal neuromuscular activation. To ensure accurate results, the correct attachment of each electrode was rechecked before each repetition.
- Revised Oswestry Pain Questionnaire (ODI). The degree of LBP imposed limitations in activity of daily ling (ADLs) was determined with Revised Oswestry Pain Questionnaire, also referred to as Oswestry Disability Index (ODI). The survey consisted of 10 questions, each with 6 possible responses scored from 0 to 5 points. If the respondent chose more than one answer to a given question, the one with higher score was recorded and subjected to the analysis. Maximum overall score amounted to 50 points, which corresponded to 100% disability due to lumbar pain.
- Roland-Morris Disability Questionnaire (RMDQ). The instrument consists of 24 statements about pain and its influence on ADLs. The respondent chooses only the statements that refer to his/her ailments. Maximum overall score may vary between 0 and 24 points.
- Visual-Analog Scale (VAS). This subjective tool is used to assess the level of pain. The participant marks the level of pain on a 10 cm scale, where 0 is no pain and 10 is the maximum pain he has ever felt.
In order to assess the impact of deep tissue massage therapy on the study population, two measurements were made over time: before and after therapy.
Ethics All measurement methods used were non-invasive and safe for health. The study was approved by the local Bioethics Committee. Each participant had the right to withdraw from the study at any stage. All collected data is anonymous and will be used only to conduct statistical analyzes for scientific purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The first step was recruitment. Based on the qualifying and disqualifying criteria, 40 people were selected. Each participant was randomly assigned to a specific group (Deep Tissue Massage (DTM) experimental group or control group). Initial measurements were collected from all participants. Participants in the DTM group had therapy, while those in the control group had no therapy. The therapist was responsible for performing the DTM therapy. Each participant in the experimental group received 4 treatments (45 minutes each, 3 days between them) over a period of 2 weeks. After the end of the whole therapy, final measurements were made. The researcher was responsible for taking measurements for each participant. The person acting as the coordinator supervised the proper course of the research. The collected data was analyzed by a person evaluating the results.
| Arm | Type | Receives |
|---|---|---|
| DTM group | Experimental | Other: Deep Tissue MassageThis group of participants (N=20) received Deep Tissue Massage therapy. |
| Control group | No intervention | –This group of participants (N=20) did not receive any intervention. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic Low-Back Pain
- office worker
Key exclusion criteria (5 listed)
- spine surgeries
- cauda equina syndrome
- cancer
- pain or motor and sensory deficits in the lower extremities below the level of the knee
- various therapies to treat chronic low-back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Tissue MassageThe Deep Tissue Massage lasted 45 minutes. The entire therapy included 4 treatments over a period of 2 weeks. The interval between treatments was 3 days. The conducted therapy included techniques for: quadratus lumborum muscle, erector spinae muscle, thoracolumbar fascia, iliopsoas muscle. All techniques were performed on both sides of the patient's body. | Other | DTM group |
Primary outcome
Lumbar anterior flexion (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day before the therapy
Lumbar anterior flexion (POST)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day after the therapy
Lumbar posterior flexion (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day before the therapy
Lumbar posterior flexion (POST)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day after the therapy
Lumbar right flexion (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day before the therapy
Lumbar right flexion (POST)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day after the therapy
Lumbar left flexion (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day before the therapy
Lumbar left flexion (POST)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day after the therapy
Lumbar right rotation (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day before the therapy
Lumbar right rotation (POST)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day after the therapy
Lumbar left rotation (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day before the therapy
Lumbar left rotation (POST)
Time frame: Through study completion, an average of 2 weeks.
Electrogoniometric measurement of the angular range of motion the day after the therapy
Stiffness (S) of the right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day before the intervention
Stiffness (S) of the right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day after the therapy
Stiffness (S) of the left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day before the therapy
Stiffness (S) of the left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day after the therapy
Elasticity (D) of the right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day before the therapy
Elasticity (D) of the right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day after the therapy
Elasticity (D) of the left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day before the therapy
Elasticity (D) of the left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day after the therapy
Muscle tone (F) of the right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day before the therapy
Muscle tone (F) of the right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day after the therapy
Muscle tone (F) of the left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day before the therapy
Muscle tone (F) of the left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Myotonometer examination of soft tissue properties the day after the therapy
Pressure pain threshold (PPT) of the right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Examination of the first discomfort threshold using an algometer the day before the therapy
Pressure pain threshold (PPT) of the right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Examination of the first discomfort threshold using an algometer the day after the therapy
Pressure pain threshold (PPT) of the left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Examination of the first discomfort threshold using an algometer the day before the therapy
Pressure pain threshold (PPT) of the left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Examination of the first discomfort threshold using an algometer the day after the therapy
EMG - MVC for right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the right longissimus muscle the day before therapy
EMG - MVC for right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the right longissimus muscle the day after the therapy
EMG - MVC for left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day before the therapy
EMG - MVC for left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day after the therapy
EMG - MVC for right iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day before the therapy
EMG - MVC for right iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the right iliocostalis muscle the day after the therapy
EMG - MVC for left iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day before the therapy
EMG - MVC for left iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left longissimus muscle the day after the therapy
EMG - MVC for right multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the right multifidus muscle the day before the therapy
EMG - MVC for right multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the right multifidus muscle the day after the therapy
EMG - MVC for left multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left multifidus muscle the day before the therapy
EMG - MVC for left multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of maximal voluntary contraction of the left multifidus muscle the day after the therapy
EMG - FR test for right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during the Flexion-Relaxation test the day before the therapy
EMG - FR test for right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during the Flexion-Relaxation test the day after the therapy
EMG - FR test for left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
EMG - FR test for left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
EMG - FR test for right iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
EMG - FR test for right iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
EMG - FR test for left iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
EMG - FR test for left iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
EMG - FR test for right multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
EMG - FR test for right multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day after the therapy
EMG - FR test for left multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the Flexion-Relaxation test the day before the therapy
EMG - FR test for left multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during the Flexion-Relaxation test the day after the therapy
EMG - sitting and standing test for right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during sitting and standing test the day before the therapy
EMG - sitting and standing test for right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during sitting and standing test the day after the therapy
EMG - sitting and standing test for left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during sitting and standing test the day before the therapy
EMG - sitting and standing test for left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during sitting and standing test the day after the therapy
EMG - sitting and standing test for right iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right iliocostalis muscle during sitting and standing test the day before the therapy
EMG - sitting and standing test for right iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right iliocostalis muscle during sitting and standing test the day after the therapy
EMG - sitting and standing test for left iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left iliocostalis muscle during sitting and standing test the day before the therapy
EMG - sitting and standing test for left iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left iliocostalis muscle during sitting and standing test the day after the therapy
EMG - sitting and standing test for right multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right multifidus muscle during sitting and standing test the day before the therapy
EMG - sitting and standing test for right multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right multifidus muscle during sitting and standing test the day after the therapy
EMG - sitting and standing test for left multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during sitting and standing test the day before the therapy
EMG - sitting and standing test for left multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during sitting and standing test the day after the therapy
EMG - weight holding test (1 kg) for right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (1 kg) for right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (1 kg) for left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (1 kg) for left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (1 kg) for right iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (1 kg) for right iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (1 kg) for left iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (1 kg) for left iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (1 kg) for right multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (1 kg) for right multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (1 kg) for left multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (1 kg) for left multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (2 kg) for right longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (2 kg) for right longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right longissimus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (2 kg) for left longissimus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (2 kg) for left longissimus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left longissimus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (2 kg) for right iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (2 kg) for right iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right iliocostalis muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (2 kg) for left iliocostalis muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (2 kg) for left iliocostalis muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left iliocostalis muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (2 kg) for right multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (2 kg) for right multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the right multifidus muscle during the weight holding test (1kg) the day after the therapy
EMG - weight holding test (2 kg) for left multifidus muscle (PRE)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day before the therapy
EMG - weight holding test (2 kg) for left multifidus muscle (POST)
Time frame: Through study completion, an average of 2 weeks.
Electromyographic measurements of the left multifidus muscle during the weight holding test (1kg) the day after the therapy
Revised Oswestry Pain Questionnaire (PRE)
Time frame: Through study completion, an average of 2 weeks.
Revised Oswestry Pain Questionnaire (ODI) - the day before therapy. The minimum score is 0, while the maximum is 50, which proves 100% disability. A higher result is worse and proves the patient's disability in everyday activities.
Revised Oswestry Pain Questionnaire (POST)
Time frame: Through study completion, an average of 2 weeks.
Revised Oswestry Pain Questionnaire (ODI) - the day after therapy. The minimum score is 0, while the maximum is 50, which proves 100% disability. A higher result is worse and proves the patient's disability in everyday activities.
Roland-Morris Disability Questionnaire (PRE)
Time frame: Through study completion, an average of 2 weeks.
Roland-Morris Disability Questionnaire (RMDQ) - the day before therapy. The minimum score is 0, while the maximum is 24. The higher the score, the worse it is and it illustrates the poor functional condition of the examined person.
Roland-Morris Disability Questionnaire (POST)
Time frame: Through study completion, an average of 2 weeks.
Roland-Morris Disability Questionnaire (RMDQ) - the day after therapy. The minimum score is 0, while the maximum is 24. The higher the score, the worse it is and it illustrates the poor functional condition of the examined person.
Visual-Analog Scale (PRE)
Time frame: Through study completion, an average of 2 weeks.
Visual-Analog Scale (VAS) - the day before therapy. The minimum score is 0 and the maximum score is 10. The higher the score, the worse it is and it reflects the subjective level of pain experienced.
Visual-Analog Scale (POST)
Time frame: Through study completion, an average of 2 weeks.
Visual-Analog Scale (VAS) - the day after therapy. The minimum score is 0 and the maximum score is 10. The higher the score, the worse it is and it reflects the subjective level of pain experienced.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 22630613Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
- Background: PubMed 27200490Williams ACC, Craig KD. Updating the definition of pain. Pain. 2016 Nov;157(11):2420-2423. doi: 10.1097/j.pain.0000000000000613. No abstract available.
- Background: PubMed 22582887Schuenke MD, Vleeming A, Van Hoof T, Willard FH. A description of the lumbar interfascial triangle and its relation with the lateral raphe: anatomical constituents of load transfer through the lateral margin of the thoracolumbar fascia. J Anat. 2012 Dec;221(6):568-76. doi: 10.1111/j.1469-7580.2012.01517.x. Epub 2012 May 15.
- Background: PubMed 21839150Tesarz J, Hoheisel U, Wiedenhofer B, Mense S. Sensory innervation of the thoracolumbar fascia in rats and humans. Neuroscience. 2011 Oct 27;194:302-8. doi: 10.1016/j.neuroscience.2011.07.066. Epub 2011 Aug 2.
- Background: PubMed 28631003Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
- Background: PubMed 18690279Nakipoglu GF, Karagoz A, Ozgirgin N. The biomechanics of the lumbosacral region in acute and chronic low back pain patients. Pain Physician. 2008 Jul-Aug;11(4):505-11.
- Background: PubMed 28686644Marshall PWM, Schabrun S, Knox MF. Physical activity and the mediating effect of fear, depression, anxiety, and catastrophizing on pain related disability in people with chronic low back pain. PLoS One. 2017 Jul 7;12(7):e0180788. doi: 10.1371/journal.pone.0180788. eCollection 2017.
- Background: PubMed 27745712Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
- Background: PubMed 31332569Le Huec JC, Thompson W, Mohsinaly Y, Barrey C, Faundez A. Sagittal balance of the spine. Eur Spine J. 2019 Sep;28(9):1889-1905. doi: 10.1007/s00586-019-06083-1. Epub 2019 Jul 22.
- Background: PubMed 29861215Koren Y, Kalichman L. Deep tissue massage: What are we talking about? J Bodyw Mov Ther. 2018 Apr;22(2):247-251. doi: 10.1016/j.jbmt.2017.05.006. Epub 2017 May 17.
- Background: PubMed 32476282Cai XY, Sun MS, Huang YP, Liu ZX, Liu CJ, Du CF, Yang Q. Biomechanical Effect of L4 -L5 Intervertebral Disc Degeneration on the Lower Lumbar Spine: A Finite Element Study. Orthop Surg. 2020 Jun;12(3):917-930. doi: 10.1111/os.12703. Epub 2020 May 31.
- Background: PubMed 19762151Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.
- Recommendations for sensor locations in trunk or (lower) back musclesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. University IPD sharing platform is under preparation. All data will also be available to researchers via the principal researcher's email (wendt@awf.poznan.pl) or Research Gate website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał Wendt, PhD principal investigator
Poznan University of Physical Education, Department of Biology and Anatomy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Tissue Massage in people with Chronic Low-back Pain, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar anterior flexion (PRE) (time frame: Through study completion, an average of 2 weeks.). The study lists 94 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690178, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.