Using biofeedback to help reduce chronic low back pain

Psychophysiological Biomarkers to Assess the Effectiveness of Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain

This study is testing if using biofeedback can help people in Pakistan with chronic low back pain feel better and reduce their pain over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 25 Years to 75 Years
• Sex: All
• Sponsor: Advanced Education & Research Center (other)
• Locations: 1 site (Karachi, Sindh)
• Trial ID: NCT06306833 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of surface electromyography (sEMG) biofeedback as a therapeutic approach for individuals suffering from chronic low back pain (CLBP) in Pakistan. It aims to address the high prevalence of CLBP, which significantly impacts physical and mental health, as well as economic productivity. Participants will be assessed based on their pain intensity and disability levels, and the intervention will focus on long-term pain reduction through biofeedback techniques. The study seeks to provide insights into a potentially effective alternative therapy for managing CLBP.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 25 to 75 who have experienced low back pain for at least three months and seek care for it.

Not a fit: Patients with chronic diseases, neurological disorders, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive and effective treatment option for patients suffering from chronic low back pain.

How similar studies have performed: While the effectiveness of biofeedback for pain management has been explored in various contexts, this specific application in the Pakistani population is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Individuals who constantly experience low back pain for the last three months.
* Individuals who seek care from healthcare provider due to low back pain
* Individuals with average pain intensity, were assessed using the Brief Pain Inventory (BPI) over the past week ≥ 2 on a 0-10 scale.
* Individuals with an average Oswestry Disability Index (ODI) score ≥ 4.
* Individuals with State-Trait Anxiety Inventory (STAI) score ≥ 20.

Exclusion Criteria:

* Age below or above 25 and 75 years, respectively.
* Females who are pregnant, lactating, or that they anticipate becoming pregnant in the next 3-6 months will be excluded.
* Individuals having any diagnosed chronic disease.
* Individuals having any diagnosed neurological disorder including Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
* Individuals having any diagnosed motor disorder or had pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
* Individuals with an active cancer
* Blind individuals
* Individuals having a body mass index greater than 35 kg/m2
* Individuals with clinical depression, that is having a score of 24 or higher on the Center for Epidemiology Depression Scale.
* Individuals who have used narcotics or muscle relaxants within 30 days before study enrollment.

Where this trial is running

Karachi, Sindh

• Psychophysiology Lab, University of Karachi — Karachi, Sindh, Pakistan (RECRUITING)

Study contacts

• Study coordinator: Amaila Fazal

Conditions: Chronic Low Back Pain