Clinical trial NCT05709925: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Group Randomized Control Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Lumbar range of motion
timeFrame: 3 weeks
Secondary outcomes:
measure: Pain Intensity
timeFrame: 3 weeks
measure: Lumbar Disability
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References: