The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain

July 30, 2024 updated by: Amaila Fazal [afazal]

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

The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic low back pain (CLBP) is a multifaceted condition with a range of adversative sequelae including mental and physical disability, social issues, and increased healthcare utilization. CLBP is one of the leading worldwide health problems however it has a benign nature. It is now accountable for more years lived with disability (YLDs) than any other chronic health problem. Chronic low back pain caused 72 million YLDs in 2013 approximately which is 1.5 times greater than that of depression and twice as high as that of diabetes. Further, in 2013, around 615 million individuals globally were affected by disabling chronic low back pain. Additionally, chronic low back pain and its accompanying disability also have a major economic burden on the country. According to an estimation, between 5 to 10% of low back pain cases will develop chronic low back pain (CLBP), which is ultimately accountable for the increased cost of treatment, a high number of sick leaves, and individual suffering and also one of the leading cause for individuals seeking health care services. Disparagingly, the issue of CLBP is not well understood in developing countries like Pakistan, Sri Lanka, India, and Bangladesh, which are in the process of development and experiencing economic development and a double burden of diseases. The chronic low back pain prevalence in Southeast Asian countries is reported to be very high, for instance much higher than that reported in the Western world. The prevalence of CLBP in Bangladesh is 64% followed by Pakistan which has a 40% prevalence rate and Sri Lanka and India 36% and 19%, respectively. Previous research studies have focused on the documentation of factors that are termed "yellow flags" which induce, aggravate, and enhance pain and disability in chronic low back pain patients. Psychological and social factors are considered important contributing factors in the bio-psychosocial approach for chronic low back pain management and its relationship with disability. Moreover, this study is in line with the United Nations' Sustainable Developmental Goals (UN-SDG) 2030 plan; Goal 3.d i.e. to "strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks". Thus, this study protocol will be a randomized controlled trial that is specifically designed to compare the biofeedback surface EMG effectiveness for chronic low back pain in the Pakistani population.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75270
        • Recruiting
        • Psychophysiology Lab, University of Karachi
        • Contact:
          • Shamoon Naushad, PhD
          • Phone Number: 03333549258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sEMG Biofeedback Intervention
Participants in the intervention group will receive biofeedback surface EMG (sEMG) therapy as an alternative therapy to reduce chronic low back pain
Other: Surface Electromyography (sEMG) Biofeedback
Biofeedback sEMG therapy through the use of virtual aids like digital therapeutics would help reduce chronic low back pain in patients by overcoming their psychophysiological manifestations. All participants in the intervention group will receive sEMG biofeedback as an alternative therapy.
No Intervention: Control
Participants in the control group will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity and interference
Time Frame: 3 Months
The Brief Pain Inventory (BPI) will be used to assess the severity of chronic low back pain and its impact on lower back functioning. Participants will rate the pain severity and the degree of interference. Using a 0-10 scale, where 0-4 corresponds to mild pain, 5-6 corresponds to moderate pain, and 7-10 corresponds to severe pain
3 Months
Lower back pain related Disability
Time Frame: 3 Months
The Oswestry Disability Index (ODI) will be used to categorize the degree of disability in CLBP patients. Each section is scored on a 0-5 scale, where 5 represents the greatest disability. The index is calculated by dividing the summed score and expressed as a percentage. Where, 0 - 20 indicates mild disability, 20 - 40% indicates moderate disability, 40 - 60% indicates severe disability, 60 - 80% indicates disabling, and 80 - 100% indicates bedridden or functional impairment.
3 Months
Quality of Life with chronic low back pain
Time Frame: 3 Months
The quality of life questionnaire will be used to assess the patient's perspective of their life quality. The score can range from 6-112. A higher score indicates a higher quality of life, where, a score of 90 is the average for a healthy population
3 Months
Pain and Disability-related Anxiety
Time Frame: 3 Months
The State-Trait Anxiety Inventory-STAI will be used for anxiety screening. It is a 20-item scale with a score range of 20-80, where higher score indicate higher levels of anxiety symptoms
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance P
Time Frame: 3 Months
Changes in the levels of Substance P will be observed during the span of the study in the control and intervention groups.
3 Months
Cortisol
Time Frame: 3 Months
Changes in the levels of Cortisol will be observed during the span of the study in the control and intervention groups.
3 Months
Beta Endorphins
Time Frame: 3 Months
Changes in the levels of Beta Endorphins will be observed during the span of the study in the control and intervention groups.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amaila Fazal [afazal]

Collaborators

University of Karachi

Investigators

  • Study Chair: Shamoon Naushad, Advanced Education & Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBP-sEMG-14022024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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