A Comparison of Two Brief Interventions for People With Chronic Low Back Pain (NCT06218459) | Clinical Trial Compass
TerminatedNot Applicable
A Comparison of Two Brief Interventions for People With Chronic Low Back Pain
Stopped: Failed to recruit to target.
United Kingdom5 participantsStarted 2024-05-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
0-10 Numeric Rating Scale for Pain Intensity
Timeframe: Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.
2
The Roland Morris Disability Questionnaire
Timeframe: Change measures at five time points, baseline, 1 week and 2, 4 and 12 weeks from baseline