Pain Education for Patients With Non-specific Low Back Pain in Nepal: A Feasibility Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acceptability of screening procedures and random allocation
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor and statistician performing data analysis will be masked for the group allocation of all the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pain education group (PEG)
Pain education based on Explain Pain developed by Moseley and Butler in 2003.
干预措施: Pain education (Other)
Control group (CG)
Evidence based physiotherapy care brief education, superficial heat, massage, and exercise.
干预措施: Control group (Other)
结局指标
主要结局
Acceptability of screening procedures and random allocation
时间窗: During the enrollment
The lead researcher will interview the physiotherapist(s) screening the patients for eligibility by asking the following open-ended question at the end of every week, "Were there any difficulties or challenges in screening and recruiting the participants the past week?" The responses will be recorded as 'Yes' or 'No'. The assessor will ask all the participants during recruitment if randomly allocating one of the two treatments is acceptable to them.
Feasibility of blinding the assessor
时间窗: Final assessment at 1 week follow up
By asking the assessor two questions at the end of the follow-up assessment: (1) Did you receive any information that indicated which group the participant belonged to? and (2) How did you receive information about which group the patients belonged to? Assessor's guess if the participants belonged to experimental or control group will be recorded. The responses will be coded as 'correct guess' or 'incorrect guess.' The frequency of "yes" and "no" as the answer to the first question will be counted. The frequency of the correct and incorrect guesses will also be counted. Finally, reasons for guesses will qualitatively analyzed.
Understanding possible contamination between the groups
时间窗: Final assessment at 1 week
Contamination between the groups will be assessed by asking all the participant of the study the following questions at the follow-up assessment: (1) "Have you talked to other participants in this study about the intervention they are receiving?"; If yes, further ask, "Was your attitude towards the intervention, or intervention changed after talking to one of the participants in the other group?"; (2) "Are you aware of the intervention that any participants in the other group are receiving in the study?"; and (3) Are any of the participants in the other group aware of the type of intervention you are receiving in this study?" Participants in the usual care group will be asked the following question: "Did you read the pain education booklet or watch the video which is one of the components of the intervention group?"
Credibility and acceptability of the interventions
时间窗: Baseline assessment and follow up 1 week assessment
It will be assessed using five questions. Responses for each of the five questions will be recorded on a Likert Scale where, 0= "Not at all", 1= "A little bit", 2= "Somewhat", 3= "Quite a bit", 4= "Very much."
Feasibility of recruitment 2: Eligibility and recruitment
时间窗: During the enrollment
The total number of participants screened, found eligible, and recruited will be recorded during the screening and recruitment process. The reasons why the participants were ineligible for inclusion in the study will be recorded for every participant who did not meet the eligibility criteria. If the participants refused to participate in the study, the reasons for refusal will be recorded. Finally, the consent rates will be recorded. The number of participants screened, who were eligible, who consented to participate, who refused to participate, reasons for exclusion and refusal will be reported as frequencies.
Adherence to the intervention
时间窗: Baseline assessment and final assessment at 1 week
Adherence to home treatment will be assessed by asking the participants in both groups to maintain a log of home treatment, in which the participants will tick mark a box for every day for a total of five days. Total number of responses will be computed by adding the number of days. Adherence will be computed by summing total number of home interventions in each group, represented by a discrete number. Reasons for non-adherence will be listed and analyzed qualitatively.
Feasibility of recruitment 1: Willingness to participate in a clinical trial
时间窗: During the enrollment
All the consecutive participants presenting at the physiotherapy department will be explained about the study and invited to participate in the study. The number of participants not willing to participate will be recorded with the reason for not wanting to participate. Total number of patients not willing to participate will be recorded with the reasons not to participate.
Satisfaction of treatment
时间窗: Final follow up assessment at 1 week
All the participants in both the groups will be assessed using Patient Global Assessment of Treatment Satisfaction (PGATS) scale.64 65 The question asked will be, ''How satisfied are you overall with the study treatment?'' on a 5-point categorical scale (0 = ''Very dissatisfied''; 1 = ''Dissatisfied''; 2 = ''Neutral or no preference''; 3 = ''Satisfied''; 4 = ''Very satisfied'') at the follow-up assessment point. Mean scores of satisfaction of treatment between the groups will be compared using a t-test.
Adverse events
时间窗: Post intervention on day 1, and at final assessment at 1 week.
All the participants in both the groups will be asked about any adverse events after the treatment. The adverse events will be recorded as a written down verbatim. The type of adverse events will be recorded. The frequency of adverse events in each group will be compared and reported.
Difficulty in understanding the information provided by the physiotherapist.
时间窗: Final follow up assessment at 1 week
All the participants in both the groups will be asked about the difficulty in understanding the information provided by the physiotherapist. The question asked will be, "How difficult was it for you to understand the information provided by the physiotherapist?" using a on a 5-point Likert Scale, where 1= "Very easy", 2= "Easy", 3= "Neither easy nor difficult", 4= "Difficult", 5= "Very difficult."
次要结局
- PROMIS pain intensity short form 3b(Baseline assessment and final assessment at 1 week)
- Global Rating of Change (GROC)(Final assessment at 1 week)
- Single-item quality-of-life (QOL) scale(Baseline assessment and final assessment at 1 week)
- Pain Catastrophizing Scale (PCS)(Baseline assessment and final assessment at 1 week)
- PROMIS emotional distress- Depression- Short form(Baseline assessment and final assessment at 1 week)
- PROMIS sleep disturbance short form 8b(Baseline assessment and final assessment at 1 week)
- 10-item Connor Davidson Resilience Scale(Baseline assessment and final assessment at 1 week)
- Patient-Reported Outcome Measurement Information System (PROMIS) pain interference short form 6b(Baseline assessment and final assessment at 1 week)
- Use of pain medications and other treatments.(Baseline assessment and final assessment at 1 week)
研究者
Saurab Sharma
Assistant Professor
Kathmandu University School of Medical Sciences