Connective Tissue Massage and Core Training in Mechanical Low Back Pain

NCT ID: NCT07193251

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-12-31

Brief Summary

This randomized controlled study will investigate the effects of connective tissue massage combined with core stabilization exercises in patients with mechanical low back pain. Participants will be assigned to two groups: one will receive core stabilization exercises with connective tissue massage, while the other will receive only core stabilization exercises. Pain will be evaluated using the Visual Analog Scale, functionality will be assessed with the Oswestry Disability Index, and endurance will be measured with static and dynamic curl-up, static back endurance, and side bridge tests. Quality of life will be assessed with the SF-36, and instrumental daily living activities will be evaluated with the Lawton & Brody Scale. The results will demonstrate whether adding connective tissue massage to core stabilization exercises will provide additional benefits in pain reduction, functional improvement, endurance, and quality of life compared to exercises alone.

Detailed Description

This randomized controlled clinical trial will evaluate the effects of connective tissue massage (CTM) combined with core stabilization exercises (CSEs) on pain, functionality, endurance, and quality of life in patients with mechanical low back pain. A total of 29-30 participants aged 20 to 55 years who will be diagnosed with mechanical low back pain will be recruited. Participants will be randomized into two groups:

Experimental group: will receive core stabilization exercises plus connective tissue massage.

Control group: will receive only core stabilization exercises.

All interventions will be delivered under physiotherapist supervision in the physiotherapy and rehabilitation laboratories. The exercise program will include progressive core stabilization exercises performed twice per week for eight weeks, each session lasting approximately 50 minutes (10 minutes warm-up, 30 minutes core stabilization, 10 minutes cool-down). The experimental group will additionally receive 20 minutes of connective tissue massage twice per week during the same 8-week intervention period.

Outcome measures will include:

Pain: Visual Analog Scale (VAS).

Functionality: Oswestry Disability Index.

Endurance: Static and dynamic curl-up, static back endurance, and horizontal side bridge tests.

Lumbar mobility: Finger-to-floor distance.

Muscle strength: Manual muscle testing.

Quality of life: Short Form-36 (SF-36).

Instrumental activities of daily living: Lawton & Brody Instrumental ADL Scale.

Assessments will be performed at baseline and after the 8-week intervention period. The study will hypothesize that connective tissue massage combined with core stabilization exercises will provide greater improvements in pain relief, functional status, muscular endurance, and quality of life compared to core stabilization exercises alone.

The results will contribute evidence on whether connective tissue massage will offer an additional therapeutic benefit when integrated into a rehabilitation program for patients with mechanical low back pain.

Conditions

Mechanical Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Core stabilization+connective tissue massage

Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed. In addition, each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort. Interventions will be delivered under physiotherapist supervision in the university physiotherapy laboratories.

Group Type: EXPERIMENTAL

Core Stabilization Exercises

Intervention Type: OTHER

Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed.

Connective tissue massage

Intervention Type: OTHER

each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort

Core Stabilization Exercises Only

Participants will receive the same supervised core stabilization program as the experimental arm (twice weekly for 8 weeks, ≈50 min per session with progressive exercises from activation to advanced tasks) and the same daily 60-min home exercise prescription. No connective tissue massage will be provided. Sessions will be delivered under physiotherapist supervision in the same laboratory setting to ensure consistency across arms.

Group Type: ACTIVE_COMPARATOR

Core Stabilization Exercises

Intervention Type: OTHER

Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed.

Interventions

Core Stabilization Exercises

Participants will receive supervised core stabilization exercises twice weekly for 8 weeks (≈50 min: 10 min warm-up, 30 min stabilization, 10 min cool-down), progressing from basic trunk activation and bridging to plank and ball-assisted tasks. A daily 60-min home program with illustrated handouts will be prescribed.

Intervention Type: OTHER

Connective tissue massage

each supervised session will include 20 min of connective tissue massage (CTM) applied bilaterally to lumbar and lower thoracic regions using oblique and transverse pulls at connective tissue reflex zones. CTM will be performed in seated or prone position depending on patient comfort

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants will be 20-55 years of age.
• Participants will have a clinician-confirmed diagnosis of mechanical low back pain and will be referred by specialists in Physical Medicine and Rehabilitation.
• Participants will have adequate cognitive ability to follow assessments and the treatment protocol and will agree to attend supervised sessions (2×/week for 8 weeks) and to perform daily home exercises.
• Participants will provide informed consent prior to any study procedures

Exclusion Criteria

• Participants will be excluded if they have a history of lumbar spine surgery.
• Participants will be excluded for conditions affecting the lumbar region, including inflammatory arthritis, tumor, or infectious diseases.
• Participants will be excluded if they present congenital anomalies of the lumbosacral region or secondary orthopedic problems that could interfere with the study.
• Participants will be excluded if they have neurological disorders (e.g.,Parkinson's disease, Alzheimer's disease, multiple sclerosis) or systemic diseases such as diabetes mellitus.
• Any medical condition judged by the investigators to preclude safe participation or adherence to the protocol will lead to exclusion.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fenerbahce University

OTHER

Sponsor Role: lead

Responsible Party

Burcu AKKURT

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biruni University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Burcu AKKURT, PhD

Role: CONTACT

burcu.akkurt@fbu.edu.tr

+905536046713

Facility Contacts

Burcu AKKURT, PhD

Role: primary

burcu.akkurt@fbu.edu.tr

+9005536046713

Other Identifiers

1234

Identifier Type: -

Identifier Source: org_study_id