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

NCT06306833 | Recruiting

• 1 other identifier: CLBP-sEMG-14022024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Substance P

  3 Months

• Cortisol

  3 Months

• Beta Endorphins

  3 Months

Study Arms (2)

sEMG Biofeedback Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the control group will receive usual care

Interventions

Surface Electromyography (sEMG) Biofeedback 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.

sEMG Biofeedback Intervention

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amaila Fazal [afazal]: lead
• University of Karachi: collaborator

Study Sites (1)

Psychophysiology Lab, University of Karachi

Karachi, Sindh, 75270, Pakistan

RECRUITING

Related Publications (12)

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  PMID: 31610090 BACKGROUND

• 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.

  PMID: 26063472 BACKGROUND

• 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.

  PMID: 25481422 BACKGROUND

• 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.

  PMID: 24665116 BACKGROUND

• 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.

  PMID: 22607834 BACKGROUND

• 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.

  PMID: 31984290 BACKGROUND

• 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.

  PMID: 32910100 BACKGROUND

• 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.

  PMID: 33061553 BACKGROUND

• 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.

  PMID: 28450787 BACKGROUND

• 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.

  PMID: 21451099 BACKGROUND

• 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.

  PMID: 30290052 BACKGROUND

• 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.

  PMID: 31846024 BACKGROUND

MeSH Terms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Shamoon Naushad

  Advanced Education & Research Center

  STUDY CHAIR

Central Study Contacts

Amaila Fazal

CONTACT

+923102686516; amaila.fazal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)