Chronic Low Back PainNCT06306833
The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain
A study testing Surface Electromyography (sEMG) Biofeedback in people with Chronic Low Back Pain, run by Amaila Fazal [afazal] at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Surface Electromyography (sEMG) Biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Psychophysiology Lab, University of Karachi
Karachi, Sindh, 75270
Shamoon Naushad, PhD, 03333549258
About this study
Official title: 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.
Read the 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
- Being tested
- Surface Electromyography (sEMG) Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Electromyography (sEMG) BiofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Surface Electromyography (sEMG) Biofeedback |
| Control | No intervention | Participants in the control group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 Months
Secondary outcomes (3)
Substance P
Changes in the levels of Substance P will be observed during the span of the study in the control and intervention groups.
Measured: 3 Months
Cortisol
Changes in the levels of Cortisol will be observed during the span of the study in the control and intervention groups.
Measured: 3 Months
Beta Endorphins
Changes in the levels of Beta Endorphins will be observed during the span of the study in the control and intervention groups.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amaila Fazal [afazal]
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi
- Responsible party
- Sponsor-investigator, Amaila Fazal [afazal], Advanced Education & Research Center
- Investigators
- Shamoon Naushad, Study chair, Advanced Education & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306833
- Sponsor's protocol ID
- CLBP-sEMG-14022024
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31610090Global 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.
PubMed 26063472Hoy 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.
PubMed 25481422Hoy 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.
PubMed 24665116Gaskin 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.
PubMed 22607834Sa 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.
PubMed 31984290Karran 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.
PubMed 32910100Khan 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.
PubMed 33061553Bishwajit 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.
PubMed 28450787Nicholas 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.
PubMed 21451099van 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.
PubMed 30290052Dwyer 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.
PubMed 31846024
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Biomarkers to Assess the Effectiveness of Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06306833
- Acronym / sponsor ID
- CLBP-sEMG-14022024
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amaila Fazal [afazal]University, hospital or other
- Collaborators
- University of Karachi
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sEMG Biofeedback Intervention | Experimental | Other: Surface Electromyography (sEMG) BiofeedbackParticipants in the intervention group will receive biofeedback surface EMG (sEMG) therapy as an alternative therapy to reduce chronic low back pain |
| Control | No intervention | –Participants in the control group will receive usual care |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface Electromyography (sEMG) BiofeedbackBiofeedback 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. | Other | sEMG Biofeedback Intervention |
Primary outcome
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
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.
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
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 secondary outcomes
Substance P
Time frame: 3 Months
Cortisol
Time frame: 3 Months
Beta Endorphins
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31610090Tagliaferri 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.
- Background: PubMed 26063472Global 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.
- Background: PubMed 25481422Hoy 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.
- Background: PubMed 24665116Hoy 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.
- Background: PubMed 22607834Gaskin 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.
- Background: PubMed 31984290Sa 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.
- Background: PubMed 32910100Karran 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.
- Background: PubMed 33061553Khan 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.
- Background: PubMed 28450787Bishwajit 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.
- Background: PubMed 21451099Nicholas 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.
- Background: PubMed 30290052van 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.
- Background: PubMed 31846024Dwyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamoon Naushad study chair
Advanced Education & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Electromyography (sEMG) Biofeedback in people with Chronic Low Back Pain, run by Amaila Fazal [afazal] at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amaila Fazal (+923102686516, amaila.fazal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity and interference (time frame: 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306833, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.