Connective Tissue Massage and Core Training in Mechanical Low Back Pain
ConditionMechanical Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorFenerbahce University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Core Stabilization Exercises
Other interventionParticipants 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
Other interventioneach 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
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Core stabilization+connective tissue massageExperimental treatment 2 interventions
Group B: Core Stabilization Exercises OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
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.
Time frame
From enrollment to the end of treatment at 8 weeks3
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.
Time frame
From enrollment to the end of treatment at 8 weeks4
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.
Time frame
From enrollment to the end of treatment at 8 weeks.Secondary outcomes
1
Finger-to-Floor Distance Test
Lumbar spine flexibility will be assessed by asking participants to bend forward with knees extended and attempt to touch the floor. The distance in centimeters between the fingertips and the floor will be measured. Smaller distances will indicate better mobility.
Time frame
From enrollment to the end of treatment at 8 weeks2
Manual Muscle Testing (MMT, Lovett Scale)
Flexibility of hip flexors, hamstrings, and lumbar extensors will be assessed through standardized muscle length tests. Presence of limited range will indicate muscle tightness.
Time frame
From enrollment to the end of treatment at 8 weeks3
Short Form-36 Health Survey (SF-36)
Health-related quality of life will be evaluated using the SF-36, consisting of 8 subscales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). Each domain is scored from 0 to 100, with higher scores reflecting better health status.
Time frame
From enrollment to the end of treatment at 8 weeks4
Lawton & Brody Instrumental Activities of Daily Living (IADL) Scale
Functional independence in daily living will be assessed with the IADL scale, which includes activities such as using the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Scores range from 0 to 24, with higher scores indicating greater independence.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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