A Comparison of Two Brief Interventions for People With Chronic Low Back Pain

NCT ID: NCT06218459

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-08-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oldpain2go®

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.

Group Type: EXPERIMENTAL

Oldpain2go®

Intervention Type: OTHER

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.

Jacobson's progressive relaxation

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

Group Type: PLACEBO_COMPARATOR

Jacobson's progressive relaxation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norton Physiotherapy

UNKNOWN

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: collaborator

Teesside University

OTHER

Sponsor Role: lead

Responsible Party

Alasdair MacSween

Principal Lecturer (Research and Innovation)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alasdair MacSween, PhD

Role: PRINCIPAL_INVESTIGATOR

Teesside University

Locations

Norton Physiotherapy Centre

Norton, Stockton-on-Tees, United Kingdom

Countries

United Kingdom

Other Identifiers

RESET 2023 Dec 17639 Macsween

Identifier Type: -

Identifier Source: org_study_id