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

NCT06796881 | Recruiting

• 1 other identifier: Dalia-003373
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessing the change of pressure pain threshold using the pressure algometer

  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

  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

  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

  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

  at baseline and after 6 weeks

Study Arms (3)

Instrument assisted soft tissue mobilization group

EXPERIMENTAL

treatment group A involved 22 patients who will receive instrumental-assisted soft tissue mobilization and exercises

Other: Instrument assisted soft tissue mobilization; Other: The conventional exercise program

Myofascial Release group

ACTIVE COMPARATOR

treatment group B involved 22 patients who will receive myofascial release and exercises

Other: Myofascial release; Other: The conventional exercise program

Exercise only group

ACTIVE COMPARATOR

control group (C) involved 22 patients who will receive exercises only.

Other: The conventional exercise program

Interventions

Instrument assisted soft tissue mobilization OTHER

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.

Instrument assisted soft tissue mobilization group

Myofascial release OTHER

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.

Myofascial Release group

The conventional exercise program OTHER

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.

Exercise only group; Instrument assisted soft tissue mobilization group; Myofascial Release group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

the Outpatient Clinic of the Police Authority Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Dalia salah Ahmed Elshatoury, physical therapist

CONTACT

+201550677823; safsafahmed53@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: January 23, 2025
• Primary Completion: May 23, 2025
• Study Completion: June 24, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)