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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Teesside University
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- The Roland Morris Disability Questionnaire
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double blind
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The Roland Morris Disability Questionnaire
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alasdair MacSween
Principal Lecturer (Research and Innovation)
Teesside University