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Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain

Primary Purpose

Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization
myofascial release
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals aged 18-50 years with diagnosed chronic mechanical low back pain. Males and females both. Participants having symptoms of duration more than 3 months. Numeric Pain Rating Scale (NPRS) score of 5 or more. Exclusion Criteria: Patient with a history of recent spinal surgery and related trauma. Participants with a history of pregnancy. Participants with a history of infection, tumor and spinal fracture. Participants with diagnosed Psychiatric Disorder.

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group A

Group B

Arm Description

Group A will be receiving moist heat for 10 minutes followed by myofascial release through stripping technique to the lumbar region. After that post-treatment stretching would be performed. Total treatment plan would be of 30 minutes, comprising of total 9 sessions (3 weeks), 3 sessions on alternate days

Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees. After that, post treatment stretching consisting of 2-3 sets of 10 repetitions of the targeted muscle group will be performed.Total treatment plan will be of 3 weeks comprising of total 9 sessions, 3 sessions on alternate days.

Outcomes

Primary Outcome Measures

Lumbar range of motion
Range of motion is the ability of a joint to go through its complete spectrum of movement and it will be measured using gravity-based inclinometer.

Secondary Outcome Measures

Pain Intensity
Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain.
Lumbar Disability
Lumbar disability will be measured using Oswestry Disability Index which is a valid and reliable tool consisting of 10 items from which patient gets to choose according to their level of function.

Full Information

First Posted
January 25, 2023
Last Updated
February 1, 2023
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05709925
Brief Title
Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain
Official Title
Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a Randomized Control Trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. Group A will be receiving myofascial release using stripping technique whereas, Group B will be receiving Instrument Assisted Soft Tissue Mobilization using long bar tool. Afterwards, post-treatment stretching would be performed in both the groups. Final assessment of pain, range of motion and disability will be done on last treatment session.
Detailed Description
Low Back Pain is a major cause of disability worldwide, affecting both genders equally at some point in their lives. 95% of low back pain is mechanical in origin which is the pain originating from spine, intervertebral discs and surrounding soft tissue structures. A total of 50 participants will be divided into two groups by coin toss method, based on the eligibility criteria. Baseline assessment of pain using NPRS, range of motion using Gravity-Based Inclinometer and disability using Oswestry Disability Index will be done on 1st session for both the groups. Group A will be receiving moist heat for 10 minutes followed by myofascial release and post-treatment stretching. Whereas, on the other hand, Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using Graston G6 long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees over lumbar area followed by post-treatment stretching. Total treatment plan will be of 3 weeks, consisting of total 9 sessions, 3 sessions on alternate days. Final assessment will be done for pain, range of motion and disability on last session at 3rd week. Gentle icing would be recommended in case of itching and bruising over the treated area.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Group Randomized Control Trial
Masking
Participant
Masking Description
Participants will be unaware of the type of the intervention they would be receiving.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Group A will be receiving moist heat for 10 minutes followed by myofascial release through stripping technique to the lumbar region. After that post-treatment stretching would be performed. Total treatment plan would be of 30 minutes, comprising of total 9 sessions (3 weeks), 3 sessions on alternate days
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees. After that, post treatment stretching consisting of 2-3 sets of 10 repetitions of the targeted muscle group will be performed.Total treatment plan will be of 3 weeks comprising of total 9 sessions, 3 sessions on alternate days.
Intervention Type
Procedure
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization
Intervention Description
The Graston Technique which is the Instrument Assisted Soft Tissue Mobilization is the use of a firm instrument to break tissue adhesions and mobilize scar tissue thus improving pain, range of motion and disability.
Intervention Type
Procedure
Intervention Name(s)
myofascial release
Intervention Description
myofascial release through stripping technique to the lumbar region.
Primary Outcome Measure Information:
Title
Lumbar range of motion
Description
Range of motion is the ability of a joint to go through its complete spectrum of movement and it will be measured using gravity-based inclinometer.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain.
Time Frame
3 weeks
Title
Lumbar Disability
Description
Lumbar disability will be measured using Oswestry Disability Index which is a valid and reliable tool consisting of 10 items from which patient gets to choose according to their level of function.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged 18-50 years with diagnosed chronic mechanical low back pain. Males and females both. Participants having symptoms of duration more than 3 months. Numeric Pain Rating Scale (NPRS) score of 5 or more. Exclusion Criteria: Patient with a history of recent spinal surgery and related trauma. Participants with a history of pregnancy. Participants with a history of infection, tumor and spinal fracture. Participants with diagnosed Psychiatric Disorder.
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

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Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain

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