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

NCT ID: NCT06306833

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-01-31

Brief Summary

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.

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Surface Electromyography (sEMG) Biofeedback

Intervention Type: OTHER

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.

Control

Participants in the control group will receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Karachi

OTHER

Sponsor Role: collaborator

Amaila Fazal [afazal]

OTHER

Sponsor Role: lead

Responsible Party

Amaila Fazal [afazal]

Research Associate

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shamoon Naushad

Role: STUDY_CHAIR

Advanced Education & Research Center

Locations

Psychophysiology Lab, University of Karachi

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Amaila Fazal

Role: CONTACT

amaila.fazal@gmail.com

+923102686516

Facility Contacts

Shamoon Naushad, PhD

Role: primary

03333549258

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Other Identifiers

CLBP-sEMG-14022024

Identifier Type: -

Identifier Source: org_study_id