Low Back PainNCT06135142
Connective Tissue Massage And Classical Massage In Patients With Chronic Non-Specific Low Back Pain.
A study testing Connective Tissue Massage, Transcutaneous Electrical Nerve Stimulation (TENS) and Classical Massage in people with Low Back Pain, run by Cansu DAL at 1 site in Turkey (Türkiye).
Trial summary
Objective This study aimed to compare the effects of connective tissue massage and classical massage on pain, functional status and quality of life in patients with chronic non-specific low back pain. Methods The study included 30 participants diagnosed with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Connective Tissue Massage, Transcutaneous Electrical Nerve Stimulation (TENS) and Classical Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2023to 10 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65,
- Diagnosis of chronic non-specific low back pain,
- Rest or activity pain score of 3 or higher on the Visual Analog Scale (VAS).
Who cannot join
- Undergoing surgical operation within the last 6 months or having prior spinal surgery,
- Presence of spondyloarthropathy, spondylolisthesis, or lumbar stenosis,
- Systemic inflammatory disease,
- Usage of non-specific anti-inflammatory medication in the past 15 days
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bayındır Devlet Hastanesi
Izmir, Bayındır, 35840
About this study
Official title: Comparison Of The Effects Of Connective Tissue Massage And Classical Massage On Pain, Functional Status And Quality Of Life In Patients With Chronic Non-Specific Low Back Pain.
Objective This study aimed to compare the effects of connective tissue massage and classical massage on pain, functional status and quality of life in patients with chronic non-specific low back pain.
Methods The study included 30 participants diagnosed with chronic non-specific low back pain. Participants were randomly divided into three groups: classical massage (n=10), connective tissue massage (n=10), and control groups (n=10). The control group received standart physical therapy only. All interventions were administered over a period of 3 days per week for 4 weeks, with each session lasting approximately 15-20 minutes. All assessments were performed at baseline and at the end of 4 weeks. For all participants, the severity of pain was assessed using the Visual Analog Scale, the level of impaired function was measured using the Functional Low Back Pain Scale, lumbar mobility was evaluated with the Modified Schober Test and Sit and Reach Test, physical disabilities were gauged using the Roland Morris Disability Questionnaire, and the quality of life was assessed using the Short Form-36 Quality of Life questionnaire.
Read the detailed description
This was a 3-arm randomized controlled trial, parallel-group study with blind outcomes assessor. Ethical approval was obtained from the Muğla Sıtkı Koçman University Health Sciences Ethics Committee (09.01.2020, decision no: 4). Detailed information about the study was verbally provided to participants, and written informed consent was obtained. The study adhered to the ethical principles of the Helsinki Declaration. The study design adhered to the CONSORT guidelines for rigorous reporting.11 After obtaining consent and confirming the inclusion criteria, a convenience sample of 30 participants was equally and randomly divided into three groups: the CTM group (n=10), CM group (n=10), and control group (n=10). Randomization was carried out by an independent physical therapist, who was not involved in the assessment or treatment of the participants, 1 hour before the baseline measurements. The randomization process involved using opaque and sealed envelopes, each containing a group allocation number generated from a computer-generated random number table. Block randomization was employed to ensure an equal distribution of participants across the groups.
All treatment sessions were administered by the same investigator (C.D) in the study group. The intervention duration was uniform across all groups: 4 consecutive weeks, with 3 sessions per week lasting 15-20 minutes per session. Outcome measurements were taken at the beginning and 4 weeks after the completion of the program. An independent physiotherapist, unaware of the research details and participant groupings, conducted the evaluations.
- Conditions
- Low Back Pain
- Being tested
- Connective Tissue Massage, Transcutaneous Electrical Nerve Stimulation (TENS), Classical Massage, Therapatic Ultrasound, Heat Treatment
- Keywords
- Low Back Pain, Connective Tissue Massage, Classical Massage, Lumbar Mobility, Quality of Life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue MassageOther
It involves manipulating the soft and deep tissues of the body.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle.
Classical MassageOther
It involves manipulating the soft tissues of the body.
Therapatic UltrasoundDevice
The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle.
Heat TreatmentOther
Applying heat to an affected area to treat damaged muscles, joints or tissues in the body.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Massage Group | Experimental | The patient was positioned in sitting position and their feet were supported.The basic region consisted of short and long strokes to the anterior superior iliac spine, the sacrolumbar angle, the ilium, L5 to T12, the pectoral muscles.After,the transition was made to the lower thoracic region.Short strokes were applied from lateral to medial on the latissimus dorsi muscle.Short strokes were executed between the transverse processes of the vertebrae from T12 to T7.Following this,long strokes were initiated from the axilla and continued up to the vertebrae.Finally,long strokes continued beneath the scapular angles.At the end of the lower thoracic region massage,the pectoral muscles were subjected to three stroking motions.After concluding the massage of the lower thoracic region,the application was finalized with long strokes performed subcostally and under the iliac crest. Receives: Other: Connective Tissue Massage |
| Classic Massage Group | Experimental | The patient positioned themselves face down with their upper clothing removed. The massage initiation involved employing a general stroking motion. Commencing from the sacrolumbar region, paravertebral long sweeping strokes were executed bilaterally, progressing upwards along the vertebrae's lateral edges. In the area spanning from the lumbothoracic boundary to the gluteals, a general stroking motion was iterated thrice. Subsequently, the erector spinae, latissimus dorsi, and gluteus maximus muscles were sequentially subjected to a series of actions: three cycles of stroking, followed by three cycles of kneading, concluding with three more cycles of stroking. As a concluding step, the initial general stroking movements were replicated thrice prior to finalizing the massage session. Receives: Other: Classical Massage |
| Control Group | Active comparator | The standardized physiotherapy program included the application of superficial thermal heat, transcutaneous electrical nerve stimulation (TENS) and therapatic Ultrasound. TENS at a frequency of 100 Hz (250-μsec pulses) was applied for 15 min using two 4- to 6-cm electrodes placed bilaterally on each side of the spinous process of the L4 to S1 vertebrae with thermal therapy. While the TENS application was in progress, the heat treatment was also applied. Topical moist heat treatment at 40°C applied directly on the skin to increase both tissue temperature and blood flow. Then, continuous ultrasound was applied at an intensity of 1.5 to 2.5 W/cm2 for a period of 5 minutes. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Therapatic Ultrasound; Other: Heat Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The VAS is a widely used, valid, and reliable measurement method for assessing pain intensity. It consists of a horizontal line drawn to a length of 10 cm, with the numbers 0 and 10 located at the left and right ends, respectively. Zero represents "no pain at all," while 10 represents "the most severe pain imaginable." As one moves from left to right along the line, the intensity of pain increases. The patient is asked to mark on the VAS where their current pain intensity lies, based on how they feel at the moment of assessment. The measurement is then recorded in centimeters using a ruler .
Measured: 4 weeks
Modified Schober Test (MST)
The MST is used to assess lumbar mobility in patients. Two Spina iliaca posterior superior landmarks are identified and connected by drawing a line to mark the midline. A point is marked 10 cm above and 5 cm below this midline. The distance between these two points should be 15 centimeters. Subsequently, the patient is asked to bend forward from the waist without bending the knees. While bending, the distance between the same two points is measured again, and the amount of change is calculated.
Measured: 4 weeks
Sit and Reach Test (SRT)
The SRT, can be utilized to assess trunk mobility or flexibility in patients with back pain. The test was performed by sit and reach box with a measuring scale. The test involved sitting on the floor with legs stretched out straight ahead. The soles of the feet were placed flat against the box. Both knees were locked and pressed flat to the floor. With the palms facing downward and the hands on top of each other, the subjects reached forward along the measuring line as far as possible. The points reached by the patients were marked and recorded.
Measured: 4 weeks
Back Pain Functional Scale (BPFS)
The BPFS is a 12-item scale used to assess how patients' activities and functions are affected by their current back pain complaints. The scale evaluates activities related to work, school, household tasks, general habits, forward bending, putting on shoes/socks, lifting objects from the ground, sleeping, sitting, standing, walking, stair climbing, and driving a car. For patients who do not drive, the final question can be answered as "travelling." Each statement is scored from 0 to 5, with a maximum score of 60 and a minimum score of 0. Higher scores indicate less difficulty in performing functional activities.
Measured: 4 weeks
Roland Morris Disability Qustionnaire (RMDQ)
The RMDQ, is a patient-administered scale consisting of 24 items used to assess patients' functional status.Patients are asked to respond to statements that correspond to their current condition, leaving blank spaces for statements that do not apply to them. Each answered statement is assigned a score of 1, and the total score of the questionnaire is calculated. The change in the total questionnaire score is used to determine the clinical improvement rate.
Measured: 4 weeks
Short Form-36 Questionnaire (SF-36)
The SF-36 is a patient-administered questionnaire consisting of 36 items used to assess an individual's quality of life. It includes two sections, namely physical health (physical functioning, physical role, pain, general health) and mental health (vitality, social functioning, emotional role, mental health), with a total of eight subdomains. Each subdomain is scored on a scale of 0 to 100. Higher scores indicate better health status.
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 posted18 Nov 2023
- Study start16 Oct 2023
- Primary completion8 May 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cansu DAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cansu DAL, Muğla Sıtkı Koçman University
- Investigators
- Cansu DAL, Principal investigator, Muğla Sıtkı Koçman UniversityMeltem KOÇ, Study director, Muğla Sıtkı Koçman UniversityBanu BAYAR, Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135142
- Sponsor's protocol ID
- CD1
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Connective Tissue Massage And Classical Massage On Pain, Functional Status And Quality Of Life In Patients With Chronic Non-Specific Low Back Pain.
- ClinicalTrials.gov ID
- NCT06135142
- Acronym / sponsor ID
- CD1
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Connective Tissue Massage, Classical Massage, Lumbar Mobility, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cansu DALUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 18 Nov 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.
Objective This study aimed to compare the effects of connective tissue massage and classical massage on pain, functional status and quality of life in patients with chronic non-specific low back pain.
Methods The study included 30 participants diagnosed with chronic non-specific low back pain. Participants were randomly divided into three groups: classical massage (n=10), connective tissue massage (n=10), and control groups (n=10). The control group received standart physical therapy only. All interventions were administered over a period of 3 days per week for 4 weeks, with each session lasting approximately 15-20 minutes. All assessments were performed at baseline and at the end of 4 weeks. For all participants, the severity of pain was assessed using the Visual Analog Scale, the level of impaired function was measured using the Functional Low Back Pain Scale, lumbar mobility was evaluated with the Modified Schober Test and Sit and Reach Test, physical disabilities were gauged using the Roland Morris Disability Questionnaire, and the quality of life was assessed using the Short Form-36 Quality of Life questionnaire.
Detailed description
This was a 3-arm randomized controlled trial, parallel-group study with blind outcomes assessor. Ethical approval was obtained from the Muğla Sıtkı Koçman University Health Sciences Ethics Committee (09.01.2020, decision no: 4). Detailed information about the study was verbally provided to participants, and written informed consent was obtained. The study adhered to the ethical principles of the Helsinki Declaration. The study design adhered to the CONSORT guidelines for rigorous reporting.11 After obtaining consent and confirming the inclusion criteria, a convenience sample of 30 participants was equally and randomly divided into three groups: the CTM group (n=10), CM group (n=10), and control group (n=10). Randomization was carried out by an independent physical therapist, who was not involved in the assessment or treatment of the participants, 1 hour before the baseline measurements. The randomization process involved using opaque and sealed envelopes, each containing a group allocation number generated from a computer-generated random number table. Block randomization was employed to ensure an equal distribution of participants across the groups.
All treatment sessions were administered by the same investigator (C.D) in the study group. The intervention duration was uniform across all groups: 4 consecutive weeks, with 3 sessions per week lasting 15-20 minutes per session. Outcome measurements were taken at the beginning and 4 weeks after the completion of the program. An independent physiotherapist, unaware of the research details and participant groupings, conducted the evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Massage Group | Experimental | Other: Connective Tissue MassageThe patient was positioned in sitting position and their feet were supported.The basic region consisted of short and long strokes to the anterior superior iliac spine, the sacrolumbar angle, the ilium, L5 to T12, the pectoral muscles.After,the transition was made to the lower thoracic region.Short strokes were applied from lateral to medial on the latissimus dorsi muscle.Short strokes were executed between the transverse processes of the vertebrae from T12 to T7.Following this,long strokes were initiated from the axilla and continued up to the vertebrae.Finally,long strokes continued beneath the scapular angles.At the end of the lower thoracic region massage,the pectoral muscles were subjected to three stroking motions.After concluding the massage of the lower thoracic region,the application was finalized with long strokes performed subcostally and under the iliac crest. |
| Classic Massage Group | Experimental | Other: Classical MassageThe patient positioned themselves face down with their upper clothing removed. The massage initiation involved employing a general stroking motion. Commencing from the sacrolumbar region, paravertebral long sweeping strokes were executed bilaterally, progressing upwards along the vertebrae's lateral edges. In the area spanning from the lumbothoracic boundary to the gluteals, a general stroking motion was iterated thrice. Subsequently, the erector spinae, latissimus dorsi, and gluteus maximus muscles were sequentially subjected to a series of actions: three cycles of stroking, followed by three cycles of kneading, concluding with three more cycles of stroking. As a concluding step, the initial general stroking movements were replicated thrice prior to finalizing the massage session. |
| Control Group | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Device: Therapatic Ultrasound, Other: Heat TreatmentThe standardized physiotherapy program included the application of superficial thermal heat, transcutaneous electrical nerve stimulation (TENS) and therapatic Ultrasound. TENS at a frequency of 100 Hz (250-μsec pulses) was applied for 15 min using two 4- to 6-cm electrodes placed bilaterally on each side of the spinous process of the L4 to S1 vertebrae with thermal therapy. While the TENS application was in progress, the heat treatment was also applied. Topical moist heat treatment at 40°C applied directly on the skin to increase both tissue temperature and blood flow. Then, continuous ultrasound was applied at an intensity of 1.5 to 2.5 W/cm2 for a period of 5 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65,
- Diagnosis of chronic non-specific low back pain,
- Rest or activity pain score of 3 or higher on the Visual Analog Scale (VAS).
Key exclusion criteria (5 listed)
- Undergoing surgical operation within the last 6 months or having prior spinal surgery,
- Presence of spondyloarthropathy, spondylolisthesis, or lumbar stenosis,
- Systemic inflammatory disease,
- Usage of non-specific anti-inflammatory medication in the past 15 days
- Pregnancy.
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 |
|---|---|---|
| Connective Tissue MassageIt involves manipulating the soft and deep tissues of the body. | Other | Connective Tissue Massage Group |
| Transcutaneous Electrical Nerve Stimulation (TENS)The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle. | Device | Control Group |
| Classical MassageIt involves manipulating the soft tissues of the body. | Other | Classic Massage Group |
| Therapatic UltrasoundThe sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle. | Device | Control Group |
| Heat TreatmentApplying heat to an affected area to treat damaged muscles, joints or tissues in the body. | Other | Control Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 4 weeks
The VAS is a widely used, valid, and reliable measurement method for assessing pain intensity. It consists of a horizontal line drawn to a length of 10 cm, with the numbers 0 and 10 located at the left and right ends, respectively. Zero represents "no pain at all," while 10 represents "the most severe pain imaginable." As one moves from left to right along the line, the intensity of pain increases. The patient is asked to mark on the VAS where their current pain intensity lies, based on how they feel at the moment of assessment. The measurement is then recorded in centimeters using a ruler .
Modified Schober Test (MST)
Time frame: 4 weeks
The MST is used to assess lumbar mobility in patients. Two Spina iliaca posterior superior landmarks are identified and connected by drawing a line to mark the midline. A point is marked 10 cm above and 5 cm below this midline. The distance between these two points should be 15 centimeters. Subsequently, the patient is asked to bend forward from the waist without bending the knees. While bending, the distance between the same two points is measured again, and the amount of change is calculated.
Sit and Reach Test (SRT)
Time frame: 4 weeks
The SRT, can be utilized to assess trunk mobility or flexibility in patients with back pain. The test was performed by sit and reach box with a measuring scale. The test involved sitting on the floor with legs stretched out straight ahead. The soles of the feet were placed flat against the box. Both knees were locked and pressed flat to the floor. With the palms facing downward and the hands on top of each other, the subjects reached forward along the measuring line as far as possible. The points reached by the patients were marked and recorded.
Back Pain Functional Scale (BPFS)
Time frame: 4 weeks
The BPFS is a 12-item scale used to assess how patients' activities and functions are affected by their current back pain complaints. The scale evaluates activities related to work, school, household tasks, general habits, forward bending, putting on shoes/socks, lifting objects from the ground, sleeping, sitting, standing, walking, stair climbing, and driving a car. For patients who do not drive, the final question can be answered as "travelling." Each statement is scored from 0 to 5, with a maximum score of 60 and a minimum score of 0. Higher scores indicate less difficulty in performing functional activities.
Roland Morris Disability Qustionnaire (RMDQ)
Time frame: 4 weeks
The RMDQ, is a patient-administered scale consisting of 24 items used to assess patients' functional status.Patients are asked to respond to statements that correspond to their current condition, leaving blank spaces for statements that do not apply to them. Each answered statement is assigned a score of 1, and the total score of the questionnaire is calculated. The change in the total questionnaire score is used to determine the clinical improvement rate.
Short Form-36 Questionnaire (SF-36)
Time frame: 4 weeks
The SF-36 is a patient-administered questionnaire consisting of 36 items used to assess an individual's quality of life. It includes two sections, namely physical health (physical functioning, physical role, pain, general health) and mental health (vitality, social functioning, emotional role, mental health), with a total of eight subdomains. Each subdomain is scored on a scale of 0 to 100. Higher scores indicate better health status.
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 3 Apr 2026.
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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.
Cansu DAL principal investigator
Muğla Sıtkı Koçman University
Meltem KOÇ study director
Muğla Sıtkı Koçman University
Banu BAYAR study director
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue Massage, Transcutaneous Electrical Nerve Stimulation (TENS) and Classical Massage in people with Low Back Pain, run by Cansu DAL 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 3 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 3 Apr 2026. 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?
Visual Analog Scale (VAS) (time frame: 4 weeks). The study lists 6 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 3 Apr 2026.