Oldpain2go®: a Randomized Pilot Virtual Feasibility Study for a Virtual Randomized Control Trial of a Novel Brief Intervention for People With Chronic Low Back Pain: RESET
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Roland Morris Disability Questionnaire
研究概览
简要总结
The goal is to undertake a Decentralized Randomized Pilot Feasibility study to inform the methods for a definitive Randomized Controlled Trial (RCT) (including recruitment success, participant experience, intervention delivery, safety, outcome measurement and sample size estimation). The main question is if the methods used are feasible for an adequately powered future RCT. Participants will be randomly allocated to receive either: Intervention - OldPain2Go® treatment or Placebo Control - Jacobson's progressive relaxation
详细描述
The project is a virtual Randomized Control Trial and the independent variable is OldPain2Go® a novel brief intervention for people with chronic low back pain. The investigators aim to answer the research question: Is OldPain2Go® an effective intervention for pain and function in people with chronic low back pain - when applied in an adequately powered RCT comparing OldPain2Go® with placebo? The Intervention arm participants will receive OldPain2Go® and the Control arm participants will receive Jacobson's progressive relaxation, as a placebo. The Control (placebo) is a commonly used element of treatment, for a wide range of conditions, but is never applied only once (or twice) as a treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind
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
- •Currently suffering from persistent, non-specific, low back pain of six or more months duration
- •No known tissue damage, structural abnormality, or pathology causing persistent low back pain
- •Aged over 18 years
- •Person's for whom Oldpain2go® is indicated as a treatment option, after the standard clinical screening process for the Oldpain2go® treatment
- •Has access to digital communication device able to host encrypted secure on-line meetings.
排除标准
- •Any Red Flags,
- •Any causative (or potentially causative) structural abnormality, or pathology detected or suspected
- •Any concurrent pathology, or condition that would render them unsuitable for on-line virtual assessment and Physiotherapy treatment
- •Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent
研究组 & 干预措施
Oldpain2go®
This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs (chronic pain) that are troubling them.
干预措施: Oldpain2go® (Other)
Jacobson's progressive relaxation
Jacobson's progressive relaxation is used in a range of conditions to relieve muscle tension and stress as part of self-management.
干预措施: Jacobson's progressive relaxation (Other)
结局指标
主要结局
The Roland Morris Disability Questionnaire
时间窗: Change measures at five time points, baseline, 1 week and 2, 4 and 12 weeks from baseline
A standard measure used in most low back pain studies to measure the degree of a person's disability. It is a 24 item, closed question, self-completed questionnaire. Each item is scored as zero or one and the minimum score is zero and maximum is 24. A higher score means greater self-rated physical disability caused by low back pain. An increase in score, over time, means an increase in self-rated physical disability caused by low back pain and a worse outcome.
0-10 Numeric Rating Scale for Pain Intensity
时间窗: Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.
A standard measure in most pain studies. Participants are asked to rate their pain on a 0-10 scale with 0 being no pain and 10 being worst imaginable pain. A higher score means greater pain. An increase in score, over time, means an increase in pain and a worse outcome.
次要结局
未报告次要终点
研究者
Alasdair MacSween
Principal Lecturer (Research and Innovation)
Teesside University