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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05709925
• Other study ID #: FUI/CTR/2022/18
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• myofascial release
myofascial release through stripping technique to the lumbar region.

Locations

Country	Name	City	State
Pakistan	Foundation University College of Physical Therapy	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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