Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pain

Not Applicable

Recruiting

• Conditions: Myofascial Release; Instrument Assisted Soft Tissue Mobilization; Chronic Low-back Pain

• Registration Number: NCT06796881
• Lead Sponsor: Cairo University

Brief Summary

This study was done to compare the effect of instrumental-assisted soft tissue mobilization versus the effect of myofascial release on pain intensity, pressure pain threshold, back function, and back range of motion in patients with chronic nonspecific low back pain.

Detailed Description

Low back pain affects 20% of the workforce annually, leading to increased work absenteeism. Chronic non specific low back pain restricts functional and occupational activities, impacting society and the economy. Treatment is often unsatisfactory, and there is no consensus on the optimal approach. Further scientific research is needed to understand the effects of facial tissue manipulation on Chronic non specific low back pain patients. The literature has not addressed the distinctions between myofascial force transmission instrumental assisted soft tissue mobilization and myofascial release on Chronic non specific low back pain patients, which could help physical therapists find effective treatments. This study is the first to include pain, Pressure pain threshold, back function, and range of motion as outcome measures and compare instrumental assisted soft tissue mobilization and myofascial release in Chronic non specific low back pain patients.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study Start: 2025-01-23
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-05-23
• Study Completion: 2025-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Patients with chronic non-specific low back pain for more than 3 months.
2. Age between 25-45 years.

Exclusion Criteria

1. Patients who have serious spinal pathologies, such as fractures, tumors or inflammatory diseases (such as ankylosing spondylitis)
2. Patients who have nerve root compromise, disk herniation, spondylolisthesis with neurological involvement, or narrowing of spinal canal
3. Pregnant women
4. Cancer patients .
5. Lower limb injuries.
6. Body mass index (BMI) greater than 25.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessing the change of pain intensity using visual analogue scale	at baseline and after 6 weeks	The visual analogue scale is a reliable tool for assessing chronic musculoskeletal pain, including chronic low back pain, with high correlations with verbal descriptive and numeric rating scales. It is a 10-cm line marked with no pain and severe pain, with higher scores indicating greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Assessing the change of pressure pain threshold using the pressure algometer	at baseline and after 6 weeks	A 1-cm diameter disk with a calibrated dial gauge is used to measure soft tissue tenderness on myofascial trigger points. The force applied to the point gradually increases, and patients are instructed to stop the algometry when experiencing a painful sensation. The force in Pascal is then read from the display.
Assessing the change of flexion range of motion of the lumbar spine using the back range of motion device	at baseline and after 6 weeks	The back range of motion II uses two Universal Inclinometers to measure range of motion to the spine, eliminating errors associated with stand-alone inclinometers. The investigator uses these inclinometers for flexion measurements, with the patient in an upright position. The therapist palpates and marks S1 and T12 on bare skin, centers the inclinometers, zeros them, and records the readings after the patient flexes forward.
Assessing the change of extension range of motion of the lumbar spine using the back range of motion device	at baseline and after 6 weeks	The back range of motion II uses two Universal Inclinometers to measure range of motion to the spine, eliminating errors associated with stand-alone inclinometers. The investigator uses these inclinometers for extension measurements, with the patient in an upright position. The therapist will repeat flexion protocol for extension having the patient extends back for full extension and will record the value
Assessing the change of lateral flexion range of motion of the lumbar spine using the back range of motion device	at baseline and after 6 weeks	The therapist will position the patient against a wall to prevent bending during lateral flexion measurements. The back range of motion unit will be adjusted until the inclinometer reads zero. For right lateral flexion, the patient will slide their hand down their leg while keeping their legs straight.
Assessing the change of rotation range of motion of the lumbar spine using the back range of motion device	at baseline and after 6 weeks	The therapist will place the back range of motion unit, so the unit's feet are in line with T12. The therapist will hold the center of the unit firmly against the patient's back and zero the compass. The therapist will have the patient slowly turn the shoulders to either side, making sure they go to full range and record the reading
Assessing the change of back function using the 5) The Arabic version of Oswestry Disability Index	at baseline and after 6 weeks	The Oswestry Disability Index is a self-reported questionnaire with 10 questions assessing daily living activities in patients with low back pain. The questions range from pain intensity to personal care and are scored on a 6-item Likert scale. The Arabic version of the oswestry disability index has good intra-observer reliability and good construct validity, with strong correlations with the visual analogue scale pain scale, Roland-Morris Low Back Pain Disability, and Quebec Back Pain Disability Scale.

Trial Locations

Locations (1)

the Outpatient Clinic of the Police Authority Hospital; 🇪🇬 Cairo, Egypt