An interventional study of Connective tissue massage and Sham connective tissue massage in Chronic Low-back Pain, sponsored by Okan University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Okan University · Not applicable, Interventional, and Treatment
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Okan University is the lead sponsor of 97 studies on the registry; 13 are open to participants now.
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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.
Exclusion Criteria:
Exercise + connective tissue massage
Other: Connective tissue massage
Exercise + sham connective tissue massage
Other: Sham connective tissue massage
Application of connective tissue massage in addition to exercise program
Application of sham connective tissue massage in addition to exercise program
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From the enrollement to 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the enrollement to 8 weeks
No study locations are listed for this record.
Start is estimated for Feb 2026; primary completion for May 2026, 3 months later.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 3 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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