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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306833
• Other study ID #: CLBP-sEMG-14022024
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Advanced Education & Research Center
• Contact: Amaila Fazal
• Phone: +923102686516
• Email: amaila.fazal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Psychophysiology Lab, University of Karachi	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Amaila Fazal [afazal]	University of Karachi

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

Bishwajit G, Tang S, Yaya S, Feng Z. Participation in physical activity and back pain among an elderly population in South Asia. J Pain Res. 2017 Apr 15;10:905-913. doi: 10.2147/JPR.S133013. eCollection 2017. — View Citation

Dwyer CP, MacNeela P, Durand H, O'Connor LL, Main CJ, McKenna-Plumley PE, Hamm RM, Reynolds B, Conneely S, Slattery BW, Taheny D, NicGabhainn S, Murphy AW, Kropmans T, McGuire BE. Effects of Biopsychosocial Education on the Clinical Judgments of Medical Students and GP Trainees Regarding Future Risk of Disability in Chronic Lower Back Pain: A Randomized Control Trial. Pain Med. 2020 May 1;21(5):939-950. doi: 10.1093/pm/pnz284. — View Citation

Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16. — View Citation

Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7. — View Citation

Hoy D, Geere JA, Davatchi F, Meggitt B, Barrero LH. A time for action: Opportunities for preventing the growing burden and disability from musculoskeletal conditions in low- and middle-income countries. Best Pract Res Clin Rheumatol. 2014 Jun;28(3):377-93. doi: 10.1016/j.berh.2014.07.006. Epub 2014 Oct 22. — View Citation

Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24. — View Citation

Karran EL, Grant AR, Moseley GL. Low back pain and the social determinants of health: a systematic review and narrative synthesis. Pain. 2020 Nov;161(11):2476-2493. doi: 10.1097/j.pain.0000000000001944. — View Citation

Khan MNU, Morrison NMV, Marshall PW. The Role of Fear-Avoidance Beliefs on Low Back Pain-Related Disability in a Developing Socioeconomic and Conservative Culture: A Cross-Sectional Study of a Pakistani Population. J Pain Res. 2020 Sep 23;13:2377-2387. doi: 10.2147/JPR.S258314. eCollection 2020. — View Citation

Nicholas MK, Linton SJ, Watson PJ, Main CJ; "Decade of the Flags" Working Group. Early identification and management of psychological risk factors ("yellow flags") in patients with low back pain: a reappraisal. Phys Ther. 2011 May;91(5):737-53. doi: 10.2522/ptj.20100224. Epub 2011 Mar 30. — View Citation

Sa KN, Moreira L, Baptista AF, Yeng LT, Teixeira MJ, Galhardoni R, de Andrade DC. Prevalence of chronic pain in developing countries: systematic review and meta-analysis. Pain Rep. 2019 Dec 6;4(6):e779. doi: 10.1097/PR9.0000000000000779. eCollection 2019 Nov-Dec. — View Citation

Tagliaferri SD, Miller CT, Owen PJ, Mitchell UH, Brisby H, Fitzgibbon B, Masse-Alarie H, Van Oosterwijck J, Belavy DL. Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective. Pain Pract. 2020 Feb;20(2):211-225. doi: 10.1111/papr.12846. Epub 2019 Nov 11. — View Citation

van Erp RMA, Huijnen IPJ, Jakobs MLG, Kleijnen J, Smeets RJEM. Effectiveness of Primary Care Interventions Using a Biopsychosocial Approach in Chronic Low Back Pain: A Systematic Review. Pain Pract. 2019 Feb;19(2):224-241. doi: 10.1111/papr.12735. Epub 2018 Dec 2. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity and interference	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
Primary	Lower back pain related Disability	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
Primary	Quality of Life with chronic low back pain	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
Primary	Pain and Disability-related Anxiety	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	Substance P	Changes in the levels of Substance P will be observed during the span of the study in the control and intervention groups.	3 Months
Secondary	Cortisol	Changes in the levels of Cortisol will be observed during the span of the study in the control and intervention groups.	3 Months
Secondary	Beta Endorphins	Changes in the levels of Beta Endorphins will be observed during the span of the study in the control and intervention groups.	3 Months