Back PainNCT05562648
Efficacy of Manual Therapy Techniques and Electrotherapy Modalities in Individuals With Non-specific Low Back Pain
A study testing Manual therapy techniques and Electrophysical agents in people with Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is the fifth most common reason for doctor visits, affecting about 60-80% of people in their lifetime. Despite this, there are not enough diagnostic and treatment methods in the literature to fully elucidate non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Manual therapy techniques and Electrophysical agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 7 Feb 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-60
- Volunteering to work
- The person has a complaint of low back pain for more than 3 months
- Diagnosis of chronic low back pain by the doctor
- Being able to read and write and be cooperative.
- Not having received treatment for the lumbar region in the last 3 months
- having an MRI in the last 6 months.
Who cannot join
- Not having any lumbar surgery or vertebral fracture
- Having neurological, radiculopathy, inflammatory, etc. disease
- Having spinal deformities such as scoliosis, kyphosis
- Having a vestibular or respiratory disorder
- Having auditory or cognitive impairment
- Medication that will affect the balance (sedatives, etc.)
Show all 9Show fewer
- Patients with lower extremity amputation
- Those who want to quit working during the study period, those who do not attend regularly.
- Conditions such as cancer, infection, etc. in the spinal region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol hospital
Istanbul, Istanbul Avrupa Kitasi, 34353
About this study
Official title: Comparison of the Efficacy of Manual Therapy Techniques and Electrotherapy Modalities in Individuals With Non-specific Low Back Pain
Low back pain is the fifth most common reason for doctor visits, affecting about 60-80% of people in their lifetime. Despite this, there are not enough diagnostic and treatment methods in the literature to fully elucidate non-specific low back pain. In this case, the research showed that non-specific low back pain should be handled with a biopsychosocial approach, and its relationship with fascia and myofascial meridians should be investigated.
Read the detailed description
According holistic that approach patients with non-specific low back pain. Instead of examining the problem of low back pain in the society only in the form of muscles, joints, ligaments, etc.; should evaluate low back pain over the fascia. It is seen that most studies in the literature only examine the painful area and tissue problems in its immediate vicinity, and therefore they approach low back pain with symptomatic treatment. In recent studies, however, the main problem is not limited to the painful area only; It has been determined that the tissue response caused by the problems in different parts of the body is transmitted to more distant regions via the fascia and myofascial meridians.
- Conditions
- Back Pain
- Being tested
- Manual therapy techniques, Electrophysical agents
- Keywords
- manuel therapy
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy techniquesOther
Myofascial trigger points are determined and the physiotherapist applies a light and continuous local pressure on them with his/her finger, usually not more than 30 seconds, until the moment of muscle relaxation, and as a result, the pain is expected to decrease to 0 (zero) and he withdraws his finger. He can do 3-5 repetitions until he sees relaxation in the muscle and reduction/disappearance of the pain.
Spinal mobilization is defined as low-speed, non-trust, passive movement within or at the limit of joint range of motion. Mobilization is low-speed, non-trust, passive joint movement.
MUSCLE ENERGY TECHNIQUES The muscle energy technique is a treatment technique that includes alternating periods of resistant muscle contractions and active-assist stretching, mostly used by osteopaths, physiotherapists, and chiropractors.
Electrophysical agentsOther
TENS TENS is a low-frequency electrical current applied to the stimulation of sensory nerves, used for the inhibition of pain sensation. Pain inhibition of TENS is based on 3 basic mechanisms. These; gate control mechanism (segmental inhibition), release of endogenous opioids and reduction of excitability with repetitive stimulation (inhibition from pattern).
Ultrasound is an effective electrotherapy modality with a deep heating feature. In addition, it has been suggested that the analgesic effect of ultrasound occurs with the stimulation of sensory afferents and the activation of the gate control mechanism in the posterior horn of the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy techniques | Experimental | Myofascial release is a soft tissue method that provides removal of adhesions and tissue tension in tissues due to overload and repetitive use. These adhesions and unbalanced tissue tensions in the tissues can cause muscle weakness, numbness, pain, tingling and burning sensation. The soft tissue is palpated by the physiotherapist and pressure is applied directly to the skin until the tissue barrier is felt in the direction of restriction. Once the tissue barrier is present, it is applied for 90-120 seconds, without slipping on the skin or forcing the tissue, until the fascia complex begins to loosen and a softening sensation is achieved. Receives: Other: Manual therapy techniques |
| Electrophysical agents | Active comparator | Evidence levels for approaches commonly used in the clinic for the treatment of chronic low back pain were generally very low to moderate. TENS (Transcutaneous Electrical Nerve Stimulation) is the most preferred application in the treatment of chronic pain in patients who receive conventional treatment in the clinic. TENS is a physiotherapy modality used to inhibit pain by stimulating the sensory nerves by applying a low frequency electrical current. Receives: Other: Electrophysical agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Questionnaire
It is a questionnaire to evaluate the disability levels and quality of life faced by patients due to low back pain. It was developed to evaluate pain-related limitation in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, sanding, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score.
Measured: 4 weeks
Beck Depression Scale
This scale has been shown to accurately measure the level of depression. The scale consists of 21 questions with 4 options, each corresponding to 0-3 points, and the patient is asked to choose the appropriate sentence according to his condition in the last week. mood, pessimism, sense of failure, dissatisfaction, sense of guilt, sense of punishment, self-hatred, self-blame, desire for self-punishment, crying spells, irritability, social introversion, indecisiveness, deterioration of body perception, determination of workability, sleep disorders, 21 symptoms and behaviors including fatigue, fatigue, decreased appetite, weight loss, somatic complaints and loss of libido are questioned.
Measured: 4 weeks
Pittsburgh Sleep Survey Index:
The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality and disturbance over the past 1-month time period. This questionnaire has seven scales including Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency (the ratio of sleep time to time in bed), Sleep Disorders (waking up at night), Sleeping Medication Use, and Daytime Dysfunction (problems caused by insomnia during the day). . Calculation of scores for these seven components yields a final score. The score for each scale ranges from 0-3, with three points on each scale indicating the maximum negative value. The total score of this questionnaire is between 0-21, and a total score greater than 5 is an indication of inadequate sleep quality.
Measured: 4 weeks
Modified Schober Test:
It is another method used to evaluate the flexibility/mobility of the lumbar spine. While the patient is standing in an upright position, the lumbosacral junction determined in accordance with the two sacroiliac joint positions is marked with a pencil. The second point is marked 5 cm below this marked point, and the third point is marked 10 cm above it. Afterwards, the patient is asked to flex the trunk as much as possible while the knees are in full extension. After the movement is completed, the newly formed distance between the second and third points is measured in "cm" with the help of a tape measure. Subtract 15 cm from the value obtained from the measurement result, and if the calculation is less than 7 cm, it is assumed that the lumbar flexibility has decreased.
Measured: 4 weeks
Secondary outcomes (2)
The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) was used to evaluate the pain intensity of patients with low back pain during movement and rest. According to the VAS, patients are asked to indicate their pain intensity by giving a number from 1 to 10, with a score of "0" if the pain sensation is no pain, and "10" if the pain sensation is the most severe.
Measured: 4 weeks
Fingertip-to-Floor Test
While the patient is standing in an upright position, the patient is asked to flex the trunk as much as possible without flexing the knees, with the hands free. The distance between the third finger of the patient and the ground is recorded with the help of a tape measure.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start3 Oct 2022
- Primary completion3 Nov 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562648
- Sponsor's protocol ID
- back pain
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Manual Therapy Techniques and Electrotherapy Modalities in Individuals With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05562648
- Acronym / sponsor ID
- back pain
- Conditions
- Back Pain
- Keywords
- manuel therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 3 Oct 2022 (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.
Low back pain is the fifth most common reason for doctor visits, affecting about 60-80% of people in their lifetime. Despite this, there are not enough diagnostic and treatment methods in the literature to fully elucidate non-specific low back pain. In this case, the research showed that non-specific low back pain should be handled with a biopsychosocial approach, and its relationship with fascia and myofascial meridians should be investigated.
Detailed description
According holistic that approach patients with non-specific low back pain. Instead of examining the problem of low back pain in the society only in the form of muscles, joints, ligaments, etc.; should evaluate low back pain over the fascia. It is seen that most studies in the literature only examine the painful area and tissue problems in its immediate vicinity, and therefore they approach low back pain with symptomatic treatment. In recent studies, however, the main problem is not limited to the painful area only; It has been determined that the tissue response caused by the problems in different parts of the body is transmitted to more distant regions via the fascia and myofascial meridians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy techniques | Experimental | Other: Manual therapy techniquesMyofascial release is a soft tissue method that provides removal of adhesions and tissue tension in tissues due to overload and repetitive use. These adhesions and unbalanced tissue tensions in the tissues can cause muscle weakness, numbness, pain, tingling and burning sensation. The soft tissue is palpated by the physiotherapist and pressure is applied directly to the skin until the tissue barrier is felt in the direction of restriction. Once the tissue barrier is present, it is applied for 90-120 seconds, without slipping on the skin or forcing the tissue, until the fascia complex begins to loosen and a softening sensation is achieved. |
| Electrophysical agents | Active comparator | Other: Electrophysical agentsEvidence levels for approaches commonly used in the clinic for the treatment of chronic low back pain were generally very low to moderate. TENS (Transcutaneous Electrical Nerve Stimulation) is the most preferred application in the treatment of chronic pain in patients who receive conventional treatment in the clinic. TENS is a physiotherapy modality used to inhibit pain by stimulating the sensory nerves by applying a low frequency electrical current. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being between the ages of 18-60
- Volunteering to work
- The person has a complaint of low back pain for more than 3 months
- Diagnosis of chronic low back pain by the doctor
- Being able to read and write and be cooperative.
Key exclusion criteria (9 listed)
- Not having any lumbar surgery or vertebral fracture
- Having neurological, radiculopathy, inflammatory, etc. disease
- Having spinal deformities such as scoliosis, kyphosis
- Having a vestibular or respiratory disorder
- Having auditory or cognitive impairment
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 |
|---|---|---|
| Manual therapy techniquesMyofascial trigger points are determined and the physiotherapist applies a light and continuous local pressure on them with his/her finger, usually not more than 30 seconds, until the moment of muscle relaxation, and as a result, the pain is expected to decrease to 0 (zero) and he withdraws his finger. He can do 3-5 repetitions until he sees relaxation in the muscle and reduction/disappearance of the pain. Spinal mobilization is defined as low-speed, non-trust, passive movement within or at the limit of joint range of motion. Mobilization is low-speed, non-trust, passive joint movement. MUSCLE ENERGY TECHNIQUES The muscle energy technique is a treatment technique that includes alternating periods of resistant muscle contractions and active-assist stretching, mostly used by osteopaths, physiotherapists, and chiropractors. | Other | Manual therapy techniques |
| Electrophysical agentsTENS TENS is a low-frequency electrical current applied to the stimulation of sensory nerves, used for the inhibition of pain sensation. Pain inhibition of TENS is based on 3 basic mechanisms. These; gate control mechanism (segmental inhibition), release of endogenous opioids and reduction of excitability with repetitive stimulation (inhibition from pattern). Ultrasound is an effective electrotherapy modality with a deep heating feature. In addition, it has been suggested that the analgesic effect of ultrasound occurs with the stimulation of sensory afferents and the activation of the gate control mechanism in the posterior horn of the spinal cord. | Other | Electrophysical agents |
Primary outcome
Oswestry Low Back Pain Disability Questionnaire
Time frame: 4 weeks
It is a questionnaire to evaluate the disability levels and quality of life faced by patients due to low back pain. It was developed to evaluate pain-related limitation in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, sanding, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score.
Beck Depression Scale
Time frame: 4 weeks
This scale has been shown to accurately measure the level of depression. The scale consists of 21 questions with 4 options, each corresponding to 0-3 points, and the patient is asked to choose the appropriate sentence according to his condition in the last week. mood, pessimism, sense of failure, dissatisfaction, sense of guilt, sense of punishment, self-hatred, self-blame, desire for self-punishment, crying spells, irritability, social introversion, indecisiveness, deterioration of body perception, determination of workability, sleep disorders, 21 symptoms and behaviors including fatigue, fatigue, decreased appetite, weight loss, somatic complaints and loss of libido are questioned.
Pittsburgh Sleep Survey Index:
Time frame: 4 weeks
The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality and disturbance over the past 1-month time period. This questionnaire has seven scales including Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency (the ratio of sleep time to time in bed), Sleep Disorders (waking up at night), Sleeping Medication Use, and Daytime Dysfunction (problems caused by insomnia during the day). . Calculation of scores for these seven components yields a final score. The score for each scale ranges from 0-3, with three points on each scale indicating the maximum negative value. The total score of this questionnaire is between 0-21, and a total score greater than 5 is an indication of inadequate sleep quality.
Modified Schober Test:
Time frame: 4 weeks
It is another method used to evaluate the flexibility/mobility of the lumbar spine. While the patient is standing in an upright position, the lumbosacral junction determined in accordance with the two sacroiliac joint positions is marked with a pencil. The second point is marked 5 cm below this marked point, and the third point is marked 10 cm above it. Afterwards, the patient is asked to flex the trunk as much as possible while the knees are in full extension. After the movement is completed, the newly formed distance between the second and third points is measured in "cm" with the help of a tape measure. Subtract 15 cm from the value obtained from the measurement result, and if the calculation is less than 7 cm, it is assumed that the lumbar flexibility has decreased.
2 secondary outcomes
The Visual Analog Scale (VAS)
Time frame: 4 weeks
Fingertip-to-Floor Test
Time frame: 4 weeks
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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy techniques and Electrophysical agents in people with Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 9 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 8 Feb 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 Turkey (Türkiye). 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?
Oswestry Low Back Pain Disability Questionnaire (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.