Connective Tissue Massage and Core Training in Mechanical Low Back Pain

NCT07193251 | Not Yet Recruiting

• 1 other identifier: 1234
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Low Back Pain

Keywords

mechanical low back pain; connective tissue massage; core stabilization exercise

Outcome Measures

Primary Outcomes (5)

• Oswestry Disability Index (ODI)

  Functional status will be assessed with the ODI, a 10-item questionnaire scored from 0 to 5 per item, covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and changing pain intensity. Scores will be converted into percentages, with higher scores indicating greater disability. The total score will be calculated as a percentage, where 0% indicates no disability and 100% represents the highest level of disability.

  From enrollment to the end of treatment at 8 weeks

• Visual Analog Scale (VAS)

  Pain intensity will be measured using the Visual Analog Scale, a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Higher scores will indicate greater pain severity.

  From enrollment to the end of treatment at 8 weeks

• Curl-Up Test (Static and Dynamic)

  Abdominal endurance will be measured by static and dynamic curl-up tests. For the static test, participants will maintain a standardized trunk-flexion position until fatigue. For the dynamic test, participants will perform as many curl-ups as possible within 1 minute. Longer holding times or higher repetitions will indicate greater endurance. Measured in seconds/repetitions, with higher values indicating greater endurance.

  From enrollment to the end of treatment at 8 weeks

• Biering-Sørensen Test

  Back extensor endurance will be evaluated by maintaining the upper body in a horizontal position over the edge of a table while the pelvis and legs are stabilized. Time will be recorded in seconds, with longer duration indicating greater endurance. Higher scores will indicate greater endurance.

  From enrollment to the end of treatment at 8 weeks.

• Side Bridge Test

  Spinal stabilizer endurance will be measured in a side-lying position with support on the elbow and feet. Participants will elevate the pelvis to align the body horizontally and maintain this position as long as possible. Longer holding times will indicate higher endurance capacity. The test will be terminated when the participant can no longer maintain the straight body position or after 240 seconds. Higher scores will indicate greater endurance.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (4)

• Finger-to-Floor Distance Test

  From enrollment to the end of treatment at 8 weeks

• Manual Muscle Testing (MMT, Lovett Scale)

  From enrollment to the end of treatment at 8 weeks

• Short Form-36 Health Survey (SF-36)

  From enrollment to the end of treatment at 8 weeks

• Lawton & Brody Instrumental Activities of Daily Living (IADL) Scale

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Core stabilization+connective tissue massage

EXPERIMENTAL

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.

Other: Core Stabilization Exercises; Other: Connective tissue massage

Core Stabilization Exercises Only

ACTIVE COMPARATOR

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.

Other: Core Stabilization Exercises

Interventions

Core Stabilization Exercises 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.

Core Stabilization Exercises Only; Core stabilization+connective tissue massage

Connective tissue massage 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+connective tissue massage

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Burcu AKKURT, PhD

CONTACT

+905536046713; burcu.akkurt@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 25, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)