Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-25 @ 3:28 AM
Study NCT ID:
NCT07193251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connective Tissue Massage and Core Training in Mechanical Low Back Pain
Sponsor:
Fenerbahce University
Organization:
Study Overview
Official Title:
The Effects of Connective Tissue Massage Combined With Core Stabilization Exercises on Pain, Functionality, and Endurance in Mechanical Low Back Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: