Clinical trial NCT06306833: The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain
Official title: Psychophysiological Biomarkers to Assess the Effectiveness of Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Advanced Education & Research Center
Sponsor class: OTHER
Collaborators: name: University of Karachi
First posted: 2024-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Intensity and interference
timeFrame: 3 Months
measure: Lower back pain related Disability
timeFrame: 3 Months
measure: Quality of Life with chronic low back pain
timeFrame: 3 Months
measure: Pain and Disability-related Anxiety
timeFrame: 3 Months
Secondary outcomes:
measure: Substance P
timeFrame: 3 Months
measure: Cortisol
timeFrame: 3 Months
measure: Beta Endorphins
timeFrame: 3 Months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Psychophysiology Lab, University of Karachi
state: Sindh
Study officials:
affiliation: Advanced Education & Research Center
name: Shamoon Naushad
role: STUDY_CHAIR
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