NCT06218459

A Comparison of Two Brief Interventions for People With 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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Teesside University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Oldpain2go®	OldPain2Go® is a non-medical intervention for the treatment of chronic pain conditions including, but not limited to Chronic Low Back Pain. The underlying premise is rooted in the biopsychosocial model of pain, where the cause of ongoing pain and the development of chronicity, is believed to lie beyond simple tissue damage, injury or malfunction. The intervention draws upon subconscious communication as a means to help patients to re-frame their pain as less threatening and remove old, out of date, pain messages that no longer serve a purpose.
OTHER	Jacobson's progressive relaxation	Jacobson's progressive relaxation is a technique commonly used for eliciting the relaxation response and relieving muscular tension. It involves sequentially relaxing various muscle groups, often starting at the head and moving down the body to the feet.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2024-01-23
• Last updated: 2025-09-08

Locations

1 site across 1 country: United Kingdom