Chronic Low-back PainNCT07462832
Effect of Connective Tissue Massage in Low Back Pain
A study testing Connective tissue massage in people with Chronic Low-back Pain, run by Okan University.
Trial summary
Connective tissue massage (CTM) is a manual therapy method that aims to modulate the autonomic response using special stroking techniques performed on connective tissue, and its analgesic effects are described in the literature. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Connective tissue massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18-65 who have had chronic low back pain in the past 6 months, have a VAS score above 3, do not have any disease that prevents them from working, and are volunteers will be included in the study.
Who cannot join
- pregnant women,
- individuals with fibromyalgia and chronic fatigue syndrome,
- individuals with uncontrolled hypertension,
- cancer, and diabetes,
- individuals with lumbar spine fractures and those who have undergone surgical interventions in the back region,
- and individuals who are unwilling or uncooperative.
About this study
Official title: Examining the Effectiveness of Connective Tissue Massage Applied in Addition to Exercise in Individuals With Chronic Low Back Pain: A Randomized Sham-Controlled Study
Connective tissue massage (CTM) is a manual therapy method that aims to modulate the autonomic response using special stroking techniques performed on connective tissue, and its analgesic effects are described in the literature. However, studies examining the effects of CTM on multidimensional parameters such as mobility, flexibility, endurance, balance, proprioception, emotional state, and quality of life, in addition to pain and disability in chronic low back pain, are limited.
This study is designed as a randomized controlled trial to evaluate the multifaceted effects of KDM applied in addition to exercise and sham massage in individuals with chronic low back pain. The study will include a total of 40 participants aged 18-65 years who have experienced low back pain for at least six months. The eight-week interventions will be conducted twice weekly; all assessments will be performed before and after treatment. The study will assess pain (VAS), functional status (RMDQ), quality of life (NHP), fatigue (FSS), sleep quality (PUKİ), lumbar mobility, flexibility, balance, core endurance, and autonomic functions.
- Conditions
- Chronic Low-back Pain
- Being tested
- Connective tissue massage, Sham connective tissue massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue massageOther
Application of connective tissue massage in addition to exercise program
Sham connective tissue massageOther
Application of sham connective tissue massage in addition to exercise program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exercise + connective tissue massage Receives: Other: Connective tissue massage |
| Sham | Sham comparator | Exercise + sham connective tissue massage Receives: Other: Sham connective tissue massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Level
Roland-Morris Disability Questionnaire: The Roland-Morris Disability Questionnaire (RMDQ) is one of the most widely used tools developed to assess the functional status of patients with low back pain. This questionnaire is a self-administered scale used to measure disability in individuals with low back pain, and it is based on selected statements from the Sickness Impact Profile.
Measured: From the enrollement to 8 weeks
Flexibility
Hamstring flexibility: The participant will be asked to raise one leg upwards without bending the knee while lying on their back. At the final point, the distance between the lateral malleolus and the bed will be measured.
Measured: From the enrollement to 8 weeks
Flexibility
Finger-to-Floor Distance (FFD) Test: The finger-to-ground lateral flexion test will be administered to assess the participant's range of motion and flexibility in spinal lateral flexion. The participant will be asked to stand with their hands flat at their sides, their heels, gluteal region, and shoulders resting against a wall. They will then be asked to bend to the side as far as possible without creating flexion or rotation movements in their torso. The distance between the distal tip of the third finger and the ground will be measured with a tape measure and recorded in centimeters.
Measured: From the enrollement to 8 weeks
Flexibility
Lumbar lateral flexion assessment: The participant will be asked to lean to the right and left while standing, without creating flexion or rotation in the torso. The distance between the tip of the middle finger and the ground will be measured.
Measured: From the enrollement to 8 weeks
Core Muscle Endurance
Core muscle static endurance will be assessed using the McGill Static Endurance Test Battery. This test will be evaluated using trunk flexion, extension, and right and left lateral bridge tests. A stopwatch will be used for measurements. Results will be recorded in seconds. The test ends when the position is compromised or the participant states they cannot continue.
Trunk Flexion Test Trunk Extension Test Lateral Bridge Test
Measured: From the enrollement to 8 weeks
Secondary outcomes (7)
Balance
Single-Leg Balance Test (Static Assessment): The participant is instructed to stand on one leg with their arms crossed over their chest, lifting one leg with the knee flexed at approximately a 45° angle, closing their eyes, and maintaining their balance in this position without opening their eyes. Once the correct position is achieved, a stopwatch is started, and the test is performed for a maximum of 30 seconds. If the participant uses their leg or arm for support, or opens their eyes, the stopwatch is stopped, and the time is recorded in seconds.
Measured: From the enrollement to 8 weeks
Balance
Functional Reach Test (Dynamic Assessment): Participants are asked to stand sideways next to a wall. Then, without touching the wall, they are instructed to raise their arm to a 90-degree shoulder flexion angle with the elbow extended and the fist closed. To determine the starting point of the test, the point where the distal end of the third metacarpal bone meets the wall is marked. The subject is then asked to reach as far as they can without lifting their heels from the ground. The new point reached by the third metacarpal bone is then marked.
Measured: From the enrollement to 8 weeks
lumbar region mobility
The Modified Schober Test will be administered to assess participants' lumbar spine flexibility. The test is administered by standing the patient with their feet 30 centimeters apart. The midpoint of the posterior superior iliac spine, corresponding to the S2 vertebra, is located. Marks are made 10 centimeters upwards and 5 centimeters downwards from this point. The participant is asked to bend forward as far as possible, keeping their arms at their sides and their knees straight. After reaching the maximum bending position, the distances between the previously marked points are measured. The resulting value is then subtracted from the previous distance of 15 centimeters between the two marked points, and the resulting value is recorded.
Measured: From the enrollement to 8 weeks
Sleep Quality
Pittsburgh Sleep Quality Index: The PUKI (Personal Sleep Quality Assessment) is a 19-item self-report scale that assesses sleep disturbance and quality over the past month. It consists of 24 questions in total. 19 of these are self-report questions answered by the patient themselves. The remaining 5 questions are answered by the patient's spouse or roommate and are used for clinical information only; they are not included in the scoring. The self-report questions cover various factors related to sleep quality. The total score ranges from 0 to 21. A total score above 5 indicates that the individual is experiencing significant sleep disturbance or mild to moderate disturbance in multiple areas.
Measured: From the enrollement to 8 weeks
Fatigue Severity
Fatigue Severity Scale: The minimum score is 9 and the maximum is 63. A total score of 36 or higher indicates severe fatigue.
Measured: From the enrollement to 8 weeks
Quality of Life Level
Nottingham Health Profile: The NHP assesses perceived social, emotional, and physical health issues. It consists of six sections: physical activity (eight items), pain (eight items), energy level (three items), emotional reactions (nine items), sleep (five items), and social isolation (five items). The scale contains a total of 38 questions. Each question is answered with a yes or no response. Each section is scored from 0 to 100, with 0 representing the best health status and 100 representing the worst.
Measured: From the enrollement to 8 weeks
Pain Severity
Visual Analog Scale: A numerical pain scale will be used to assess pain during activity, rest, and night. This scale is an 11-point scale scored from 0 to 10: "0" = no pain, "10" = the most severe pain imaginable. Participants verbally choose the value that best reflects the severity of pain they experienced in the past 24 hours.
Measured: From the enrollement to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start9 Feb 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Çağla Balkışlı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462832
- Sponsor's protocol ID
- 2025-12-26
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Connective Tissue Massage Applied in Addition to Exercise in Individuals With Chronic Low Back Pain: A Randomized Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT07462832
- Acronym / sponsor ID
- 2025-12-26
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
Connective tissue massage (CTM) is a manual therapy method that aims to modulate the autonomic response using special stroking techniques performed on connective tissue, and its analgesic effects are described in the literature. However, studies examining the effects of CTM on multidimensional parameters such as mobility, flexibility, endurance, balance, proprioception, emotional state, and quality of life, in addition to pain and disability in chronic low back pain, are limited.
This study is designed as a randomized controlled trial to evaluate the multifaceted effects of KDM applied in addition to exercise and sham massage in individuals with chronic low back pain. The study will include a total of 40 participants aged 18-65 years who have experienced low back pain for at least six months. The eight-week interventions will be conducted twice weekly; all assessments will be performed before and after treatment. The study will assess pain (VAS), functional status (RMDQ), quality of life (NHP), fatigue (FSS), sleep quality (PUKİ), lumbar mobility, flexibility, balance, core endurance, and autonomic functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Connective tissue massageExercise + connective tissue massage |
| Sham | Sham comparator | Other: Sham connective tissue massageExercise + sham connective tissue massage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants aged 18-65 who have had chronic low back pain in the past 6 months, have a VAS score above 3, do not have any disease that prevents them from working, and are volunteers will be included in the study.
Key exclusion criteria (6 listed)
- pregnant women,
- individuals with fibromyalgia and chronic fatigue syndrome,
- individuals with uncontrolled hypertension,
- cancer, and diabetes,
- individuals with lumbar spine fractures and those who have undergone surgical interventions in the back region,
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 massageApplication of connective tissue massage in addition to exercise program | Other | Intervention |
| Sham connective tissue massageApplication of sham connective tissue massage in addition to exercise program | Other | Sham |
Primary outcome
Disability Level
Time frame: From the enrollement to 8 weeks
Roland-Morris Disability Questionnaire: The Roland-Morris Disability Questionnaire (RMDQ) is one of the most widely used tools developed to assess the functional status of patients with low back pain. This questionnaire is a self-administered scale used to measure disability in individuals with low back pain, and it is based on selected statements from the Sickness Impact Profile.
Flexibility
Time frame: From the enrollement to 8 weeks
Hamstring flexibility: The participant will be asked to raise one leg upwards without bending the knee while lying on their back. At the final point, the distance between the lateral malleolus and the bed will be measured.
Flexibility
Time frame: From the enrollement to 8 weeks
Finger-to-Floor Distance (FFD) Test: The finger-to-ground lateral flexion test will be administered to assess the participant's range of motion and flexibility in spinal lateral flexion. The participant will be asked to stand with their hands flat at their sides, their heels, gluteal region, and shoulders resting against a wall. They will then be asked to bend to the side as far as possible without creating flexion or rotation movements in their torso. The distance between the distal tip of the third finger and the ground will be measured with a tape measure and recorded in centimeters.
Flexibility
Time frame: From the enrollement to 8 weeks
Lumbar lateral flexion assessment: The participant will be asked to lean to the right and left while standing, without creating flexion or rotation in the torso. The distance between the tip of the middle finger and the ground will be measured.
Core Muscle Endurance
Time frame: From the enrollement to 8 weeks
Core muscle static endurance will be assessed using the McGill Static Endurance Test Battery. This test will be evaluated using trunk flexion, extension, and right and left lateral bridge tests. A stopwatch will be used for measurements. Results will be recorded in seconds. The test ends when the position is compromised or the participant states they cannot continue. Trunk Flexion Test Trunk Extension Test Lateral Bridge Test
7 secondary outcomes
Balance
Time frame: From the enrollement to 8 weeks
Balance
Time frame: From the enrollement to 8 weeks
lumbar region mobility
Time frame: From the enrollement to 8 weeks
Sleep Quality
Time frame: From the enrollement to 8 weeks
Fatigue Severity
Time frame: From the enrollement to 8 weeks
Quality of Life Level
Time frame: From the enrollement to 8 weeks
Pain Severity
Time frame: From the enrollement to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue massage in people with Chronic Low-back Pain, run by Okan University.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Disability Level (time frame: From the enrollement to 8 weeks). The study lists 5 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 10 Mar 2026.