Clinical trial NCT03387228: Pain Education for Patients With Low Back Pain in Nepal: A Feasibility Study
Official title: Pain Education for Patients With Non-specific Low Back Pain in Nepal: A Feasibility Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: back pain
low back pain
Explain Pain
Pain education
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of Otago
name: University of Washington
name: University of South Australia
First posted: 2018-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility of a two group randomized clinical trial.
Primary purpose: OTHER

Brief summary: The primary aim of this study is to evaluate the feasibility of a full randomized clinical trial for assessing the effects of pain education as an intervention for patients with LBP in a physiotherapy facility in Nepal. The primary objectives of the study are related to feasibility of randomized clinical trial including: (1) willingness to participate in a clinical trial, (2) acceptability of random allocation to one of the two study groups, (3) feasibility of blinding the assessor(s), (4) eligibility and recruitment rates, (5) acceptability of screening procedures, (6) possible contamination between the groups, (7) credibility of pain education for patients with LBP, (8) adherence to intervention, (9) satisfaction of treatment, and (10) difficulty in understanding the content of pain education.

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: This is a feasibility study that is being performed to determine if a full randomized controlled trial (RCT) can be successfully conducted and if it should be conducted. The definition of a feasibility study highlights the question, "Can this study be done?" The SPIRIT statement and the CONSORT statement- extension to pilot and feasibility randomized study will be followed in the planning and reporting of the protocol and the manuscript of this feasibility study respectively.

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).

Eligibility criteria: Inclusion Criteria:

* Nonspecific LBP (LBP other than those excluded, see exclusion criteria below),
* any duration with pain,
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of recruitment 1: Willingness to participate in a clinical trial
timeFrame: During the enrollment
measure: Feasibility of recruitment 2: Eligibility and recruitment
timeFrame: During the enrollment
measure: Feasibility of blinding the assessor
timeFrame: Final assessment at 1 week follow up
measure: Acceptability of screening procedures and random allocation
timeFrame: During the enrollment
measure: Understanding possible contamination between the groups
timeFrame: Final assessment at 1 week
measure: Credibility and acceptability of the interventions
timeFrame: Baseline assessment and follow up 1 week assessment
measure: Adherence to the intervention
timeFrame: Baseline assessment and final assessment at 1 week
measure: Satisfaction of treatment
timeFrame: Final follow up assessment at 1 week
measure: Difficulty in understanding the information provided by the physiotherapist.
timeFrame: Final follow up assessment at 1 week
measure: Adverse events
timeFrame: Post intervention on day 1, and at final assessment at 1 week.
Secondary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS) pain interference short form 6b
timeFrame: Baseline assessment and final assessment at 1 week
measure: PROMIS pain intensity short form 3b
timeFrame: Baseline assessment and final assessment at 1 week
measure: Single-item quality-of-life (QOL) scale
timeFrame: Baseline assessment and final assessment at 1 week
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline assessment and final assessment at 1 week
measure: Global Rating of Change (GROC)
timeFrame: Final assessment at 1 week
measure: PROMIS sleep disturbance short form 8b
timeFrame: Baseline assessment and final assessment at 1 week
measure: PROMIS emotional distress- Depression- Short form
timeFrame: Baseline assessment and final assessment at 1 week
measure: 10-item Connor Davidson Resilience Scale
timeFrame: Baseline assessment and final assessment at 1 week
measure: Use of pain medications and other treatments.
timeFrame: Baseline assessment and final assessment at 1 week
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Sahara Physiotherapy Hospital
Study officials:
affiliation: Kathmandu University School of Medical Sciences
name: Saurab Sharma, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.