Pain Education for Patients With Low Back Pain in Nepal: A Feasibility Study
NCT ID: NCT03387228
Last Updated: 2018-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-02-16
2018-04-30
Brief Summary
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To address the study objectives, an assessor-blinded, two arm randomized feasibility study was designed. Forty patients with LBP will be randomly allocated to one of the two study arms, (1) pain education in the experimental group, and (2) evidence based care in the control group (CG).
Detailed Description
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The study will be assessor blind two-arm feasibility clinical trial study. Ethical approval was obtained from the Nepal Health Research Council (NHRC) and University of Otago Human Ethics Committee. The study will be conducted in the Sahara Rehabilitation Hospital, Kathmandu, Nepal which is a private hospital in Kathmandu, Nepal.
Overview of the study: Advertisement of the study will be made in social media. Interested candidates will be screened for eligibility. Eligible patients with LBP will be enrolled in the study. Participants will be randomly assigned to one of the two groups. All the participants in the experimental group will receive pain education and those in the control group will receive usual (evidence based) physiotherapy care. All the participants will be assessed at baseline, and follow-up assessment approximately after a week of randomization.
Participant screening and recruitment: Consecutive participants with non-specific low back pain will be invited to participate in this study. Interested candidates will be explained the study purpose, benefits and harms of the intervention, time required for the completion of the study, follow-up duration, voluntary nature of participation, cost of participation, and the rights to withdraw from the study at any point. A participant information sheet will be provided to all potential participants. If the potential participants are interested in participating, they will be screened for eligibility by a research assistant who is a physiotherapist. If the participants are found eligible, informed consent will be obtained. For those who cannot sign the consent, a witness will sign on their behalf, or the study participant will provide a thumb print on the form for those who cannot write or sign the form as per the ethical guidelines provided by NHRC. Patients with no education and who cannot sign an informed consent will be included in order to increase the inclusion of uneducated or low education group, given that 31% people in Nepal who are five years old or more cannot read and write. Additionally, exploration of feasibility of pain education in those with no schooling or low educational attainment is important in order to inform clinical practice.
Participants will be informed that they will receive one of the two treatments randomly. It will be highlighted that both of the treatment options are thought to be effective for low back pain, and that the goal of the main study is to compare the interventions, however the current study will more specifically evaluate the feasibility of such a study. There will be no restriction on the participants on both the groups in the pharmacological interventions they receive, however, participants in the intervention group will be restricted on receiving other physiotherapy interventions on day 1 only. All the participants will continue to receive the regular interventions provided by the centre from the second visit after follow-up assessment in the second week.
Group Allocation, Randomization and Blinding: Random number sequence will be generated by a researcher not involved in data collection or providing treatment using www.random.org. Allocation concealment will be performed using opaque, sealed envelopes. The participants will be allocated to one of the two groups by a hospital staff who is not the assessor. The two groups are: Group 1: Pain education group (PEG); and Group 2: Control group (CG).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Pain education group (PEG)
Pain education based on Explain Pain developed by Moseley and Butler in 2003.
Pain education
Pain education intervention we plan to use is based on Explain Pain developed by Moseley and Butler in 2003. The pain education handout and materials produced in Nepali will be proof-read and pre-tested in 5 - 10 Nepalese with LBP as needed, and corrected, if necessary.
Dosage: A single (approximately) one hour pain education will be delivered to the PEG.
Home advice: A printed handout of the pain education material will be provided only to the study participants in the PEG. Participants will be advised to read them (or have family members read them), followed by walking for 30 minutes.
Control group (CG)
Evidence based physiotherapy care brief education, superficial heat, massage, and exercise.
Control group
The control participants will receive physiotherapy care based on the recent clinical practice guidelines. This control group intervention will comprise of: (1) education (advice to remain active); (2) massage to back; (3) superficial heat; and (4) static cycling or (treadmill) walking with the aim to promote physical activity. Although superficial heat is recommended in the acute/subacute LBP, we included this as a common treatment for all types of LBP including chronic LBP, which could be a part of self-management.
Duration of treatment: 1 hour. Home advice: Participants will be advised to self-manage their back pain based on the information provided. Home exercise leaflet with emphasis on the value of exercise to increase strength and endurance, followed by a 30 minutes walking.
Interventions
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Pain education
Pain education intervention we plan to use is based on Explain Pain developed by Moseley and Butler in 2003. The pain education handout and materials produced in Nepali will be proof-read and pre-tested in 5 - 10 Nepalese with LBP as needed, and corrected, if necessary.
Dosage: A single (approximately) one hour pain education will be delivered to the PEG.
Home advice: A printed handout of the pain education material will be provided only to the study participants in the PEG. Participants will be advised to read them (or have family members read them), followed by walking for 30 minutes.
Control group
The control participants will receive physiotherapy care based on the recent clinical practice guidelines. This control group intervention will comprise of: (1) education (advice to remain active); (2) massage to back; (3) superficial heat; and (4) static cycling or (treadmill) walking with the aim to promote physical activity. Although superficial heat is recommended in the acute/subacute LBP, we included this as a common treatment for all types of LBP including chronic LBP, which could be a part of self-management.
Duration of treatment: 1 hour. Home advice: Participants will be advised to self-manage their back pain based on the information provided. Home exercise leaflet with emphasis on the value of exercise to increase strength and endurance, followed by a 30 minutes walking.
Eligibility Criteria
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Exclusion Criteria
* pain primarily localized between T12 and gluteal folds,
* age 18 years or older,
* average pain intensity reported as moderate, or severe, or very severe on a PROMIS five- point PROMIS Pain Intensity Short-form Scale over the past week,
* is a Nepalese and is able to understand and speak Nepali fluently.
* Participants with likely specific causes of LBP will be excluded using a triage procedure as suggested by Bardin and colleagues,
* having history of prolonged use of corticosteroid,
* history of malignancy,
* recent history of fever or chills,
* history of other diseases associated with compromise in immune system,
* history of recent spinal surgery or dental procedures,
* history of recent history of trauma to spine or a spine fracture,
* history of bladder and bowel dysfunction,
* history of perineal or saddle anaesthesia,
* history of weakness of lower extremity or loss of sensation in lower extremity. -
* current pregnancy,
* history of diagnosed mental health conditions (e.g., schizophrenia, bipolar disorder, major depressive disorder) that would limit successful participation.
18 Years
ALL
No
Sponsors
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University of Otago
OTHER
University of Washington
OTHER
University of South Australia
OTHER
Kathmandu University School of Medical Sciences
OTHER
Responsible Party
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Saurab Sharma
Assistant Professor
Principal Investigators
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Saurab Sharma, MPT
Role: PRINCIPAL_INVESTIGATOR
Kathmandu University School of Medical Sciences
Locations
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Sahara Physiotherapy Hospital
Kathmandu, , Nepal
Countries
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References
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Sharma S, Jensen MP, Moseley GL, Abbott JH. Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. BMJ Open. 2019 Mar 27;9(3):e026874. doi: 10.1136/bmjopen-2018-026874.
Sharma S, Jensen MP, Moseley GL, Abbott JH. Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial). BMJ Open. 2018 Aug 10;8(8):e022423. doi: 10.1136/bmjopen-2018-022423.
Other Identifiers
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NHRC-422/2017
Identifier Type: -
Identifier Source: org_study_id