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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: myofascial release; Procedure: Instrument Assisted Soft Tissue Mobilization

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Foundation University College of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks
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.	3 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2022
• Primary Completion (ANTICIPATED): March 30, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FUI/CTR/2022/18

Drug and device information, study documents

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