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Starting soon Not applicable

Connective Tissue Massage and Core Training in Mechanical Low Back Pain

NCT07193251 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2025-09-25

Condition(s) studied

Mechanical Low Back Pain

Investigational drug(s) / intervention(s)

Core Stabilization ExercisesConnective tissue massage

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
55 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Oswestry Disability Index (ODI) — From enrollment to the end of treatment at 8 weeks
    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.
  • Visual Analog Scale (VAS) — From enrollment to the end of treatment at 8 weeks
    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.
  • Curl-Up Test (Static and Dynamic) — From enrollment to the end of treatment at 8 weeks
    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.
  • Biering-Sørensen Test — From enrollment to the end of treatment at 8 weeks.
    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.
  • Side Bridge Test — From enrollment to the end of treatment at 8 weeks.
    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.

Trial sites (1)

FacilityCityRegionStatus
Biruni University Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07193251 on ClinicalTrials.gov ↗ ← All trials in Turkey