Effect of Connective Tissue Massage in Low Back Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Connective tissue massage; Other: Sham connective tissue massage

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Exercise + connective tissue massage	Other: Connective tissue massage; Application of connective tissue massage in addition to exercise program
Sham Comparator: Sham; Exercise + sham connective tissue massage	Other: Sham connective tissue massage; Application of sham connective tissue massage in addition to exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	From the enrollement to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From the enrollement to 8 weeks

Collaborators and Investigators

• Sponsor: Okan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-12-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No