Effect of Connective Tissue Massage in Low Back Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOkan University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

pregnant women,

individuals with fibromyalgia and chronic fatigue syndrome,

individuals with uncontrolled hypertension,

cancer, and diabetes,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Connective tissue massage

    Other intervention

    Application of connective tissue massage in addition to exercise program

  • Sham connective tissue massage

    Other intervention

    Application of sham connective tissue massage in addition to exercise program

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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