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

NCT ID: NCT06796881

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2025-06-24

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Instrument assisted soft tissue mobilization group

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

Group Type EXPERIMENTAL

Instrument assisted soft tissue mobilization

Intervention Type 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.

The conventional exercise program

Intervention Type 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.

Myofascial Release group

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

Group Type ACTIVE_COMPARATOR

Myofascial release

Intervention Type 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.

The conventional exercise program

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

The conventional exercise program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Salah Ahmed elshatoury

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Outpatient Clinic of the Police Authority Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dalia salah Ahmed Elshatoury, physical therapist

Role: CONTACT

+201550677823

Facility Contacts

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Dalia Salah Ahmed Elshatoury, physical therapist

Role: primary

+201550677823

Other Identifiers

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Dalia-003373

Identifier Type: -

Identifier Source: org_study_id

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