A Comparison of Two Brief Interventions for People with Chronic Low Back Pain (RESET)

Teesside University

Status: Enrolling

Conditions: Low Back Pain

Treatments: Other: Jacobson's progressive relaxation; Other: Oldpain2go®

Study type: Interventional

Funder types: Other

Identifiers

NCT06218459

RESET 2023 Dec 17639 Macsween

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Oldpain2go®

Experimental group

Description:

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.

Treatment:

Other: Oldpain2go®

Jacobson's progressive relaxation

Placebo Comparator group

Description:

Jacobson's progressive relaxation is used in a range of conditions to relieve muscle tension and stress as part of self-management.

Treatment:

Other: Jacobson's progressive relaxation