Effect of Connective Tissue Massage in Low Back Pain

NCT07462832 | Not Yet Recruiting

• 1 other identifier: 2025-12-26
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Balance

  From the enrollement to 8 weeks

• Balance

  From the enrollement to 8 weeks

• lumbar region mobility

  From the enrollement to 8 weeks

• Sleep Quality

  From the enrollement to 8 weeks

• Fatigue Severity

  From the enrollement to 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Exercise + connective tissue massage

Other: Connective tissue massage

Sham

SHAM COMPARATOR

Exercise + sham connective tissue massage

Other: Sham connective tissue massage

Interventions

Connective tissue massage OTHER

Application of connective tissue massage in addition to exercise program

Intervention

Sham connective tissue massage OTHER

Application of sham connective tissue massage in addition to exercise program

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 10, 2026
• Study Start: February 9, 2026
• Primary Completion: May 15, 2026
• Study Completion: July 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03