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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain; Instrument Assisted Soft Tissue Mobilization; Myofascial Release
• Intervention / Treatment: Other: Instrument assisted soft tissue mobilization; Other: The conventional exercise program; Other: Myofascial release

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 Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dalia Salah Ahmed Elshatoury, physical therapist; Phone Number: +201550677823; Email: safsafahmed53@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • the Outpatient Clinic of the Police Authority Hospital
    • Contact: Dalia Salah Ahmed Elshatoury, physical therapist; Phone Number: +201550677823; Email: safsafahmed53@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instrument assisted soft tissue mobilization group; treatment group A involved 22 patients who will receive instrumental-assisted soft tissue mobilization and exercises	Other: Instrument assisted soft tissue mobilization; The group will undergo Instrument assisted soft tissue mobilization using M2Tblade, applying it for 40-120 seconds until hyperemia occurs. After treatment, ice packs will be applied for 5 minutes to reduce hyperemia. The therapist will ensure comfort through continuous communication and reporting any discomfort.; Other: The conventional exercise program; Patients will undergo a 12-session exercise program for 6 weeks, consisting of straight leg raising, bridging exercise, prone hip extension exercise, and abdominal curl exercise. The exercises will be done 3 sets, 10 repetitions each, with 1 minute rest between each set. The abdominal curl exercises involve supine or hook-lying positions with the lumbar spine neutral, with the patient performing a drawing in maneuver to stabilize the abdominal muscles. The progression involves lifting the shoulders, changing arm positions, and holding a weight or medicine ball. The patient's position is hook-lying, maintaining a neutral spinal position.
Active Comparator: Myofascial Release group; treatment group B involved 22 patients who will receive myofascial release and exercises	Other: The conventional exercise program; Patients will undergo a 12-session exercise program for 6 weeks, consisting of straight leg raising, bridging exercise, prone hip extension exercise, and abdominal curl exercise. The exercises will be done 3 sets, 10 repetitions each, with 1 minute rest between each set. The abdominal curl exercises involve supine or hook-lying positions with the lumbar spine neutral, with the patient performing a drawing in maneuver to stabilize the abdominal muscles. The progression involves lifting the shoulders, changing arm positions, and holding a weight or medicine ball. The patient's position is hook-lying, maintaining a neutral spinal position.; Other: Myofascial release; The therapist will use a cross-hand release technique to release the lumbar spine, ensuring the patient is prone and suitable. They will lean into the patient to the tissue depth barrier, wait, and follow each release, avoiding force or slipping. The technique will be applied for 5 minutes on each side.
Active Comparator: Exercise only group; control group (C) involved 22 patients who will receive exercises only.	Other: The conventional exercise program; Patients will undergo a 12-session exercise program for 6 weeks, consisting of straight leg raising, bridging exercise, prone hip extension exercise, and abdominal curl exercise. The exercises will be done 3 sets, 10 repetitions each, with 1 minute rest between each set. The abdominal curl exercises involve supine or hook-lying positions with the lumbar spine neutral, with the patient performing a drawing in maneuver to stabilize the abdominal muscles. The progression involves lifting the shoulders, changing arm positions, and holding a weight or medicine ball. The patient's position is hook-lying, maintaining a neutral spinal position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the change of pain intensity using visual analogue scale	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.	at baseline and after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the change of pressure pain threshold using the pressure algometer	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.	at baseline and after 6 weeks
Assessing the change of flexion range of motion of the lumbar spine using the back range of motion device	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.	at baseline and after 6 weeks
Assessing the change of extension range of motion of the lumbar spine using the back range of motion device	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	at baseline and after 6 weeks
Assessing the change of lateral flexion range of motion of the lumbar spine using the back range of motion device	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.	at baseline and after 6 weeks
Assessing the change of rotation range of motion of the lumbar spine using the back range of motion device	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	at baseline and after 6 weeks
Assessing the change of back function using the 5) The Arabic version of Oswestry Disability Index	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.	at baseline and after 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Estimated): May 23, 2025
• Study Completion (Estimated): June 24, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Dalia-003373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No