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

Sponsor
Foundation University Islamabad (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05709925
Collaborator
(none)
50
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2
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4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Instrument Assisted Soft Tissue Mobilization
  • Procedure: myofascial release
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Group Randomized Control TrialParallel Group Randomized Control Trial
Masking:
Single (Participant)
Masking Description:
Participants will be unaware of the type of the intervention they would be receiving.
Primary Purpose:
Treatment
Official Title:
Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain
Actual Study Start Date :
Aug 11, 2022
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Group A

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

Procedure: myofascial release
myofascial release through stripping technique to the lumbar region.

Experimental: Group B

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.

Procedure: Instrument Assisted Soft Tissue Mobilization
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.

Outcome Measures

Primary Outcome Measures

  1. Lumbar range of motion [3 weeks]

    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

  1. Pain Intensity [3 weeks]

    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.

  2. Lumbar Disability [3 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Foundation University College of Physical Therapy Rawalpindi Punjab Pakistan 46000

Sponsors and Collaborators

  • Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Foundation University Islamabad
ClinicalTrials.gov Identifier:
NCT05709925
Other Study ID Numbers:
  • FUI/CTR/2022/18
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023