Comparing two brief interventions for chronic low back pain
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
This study is testing whether a new treatment called OldPain2Go® can help people with chronic low back pain feel better compared to a relaxation technique.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teesside University Academic / other |
| Locations | 1 site (Norton, Stockton-on-Tees) |
| Trial ID | NCT06218459 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of two brief interventions for individuals suffering from chronic low back pain. Participants will be randomly assigned to receive either the OldPain2Go® treatment or a placebo control involving Jacobson's progressive relaxation. The study will assess various factors including recruitment success, participant experience, intervention delivery, safety, and outcome measurement to inform a future larger randomized controlled trial. The focus is on determining if the OldPain2Go® intervention is effective in improving pain and function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old suffering from persistent, non-specific low back pain for six months or more without known structural abnormalities.
Not a fit: Patients with any structural abnormalities, concurrent pathologies, or those unable to participate in online assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and effective treatment option for patients with chronic low back pain.
How similar studies have performed: While the specific intervention OldPain2Go® is novel, similar studies exploring brief interventions for chronic pain have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Norton, Stockton-on-Tees
- Norton Physiotherapy Centre — Norton, Stockton-on-Tees, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alasdair MacSween, PhD — Teesside University
- Study coordinator: Alasdair MacSween, PhD
- Email: a.macsween@tees.ac.uk
- Phone: +44 01642 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.