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

Low Back Pain Clinical Trial

— RESET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218459
• Other study ID #: RESET 2023 Dec 17639 Macsween
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Teesside University
• Contact: Alasdair MacSween, PhD
• Phone: +44 01642 34
• Email: a.macsween[@]tees.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 31, 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Norton Physiotherapy Centre	Norton	Stockton-on-Tees

Sponsors (3)

Lead Sponsor	Collaborator
Teesside University	Newcastle University, Norton Physiotherapy

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	0-10 Numeric Rating Scale for Pain Intensity	A standard measure in most pain studies. Participants are asked to rate their pain on a 0-10 scale with 0 being no pain and 10 being worst imaginable pain.; A higher score means greater pain. An increase in score, over time, means an increase in pain and a worse outcome.	Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.
Primary	The Roland Morris Disability Questionnaire	A standard measure used in most low back pain studies to measure the degree of a person's disability. It is a 24 item, closed question, self-completed questionnaire. Each item is scored as zero or one and the minimum score is zero and maximum is 24.; A higher score means greater self-rated physical disability caused by low back pain. An increase in score, over time, means an increase in self-rated physical disability caused by low back pain and a worse outcome.	Change measures at five time points, baseline, 1 week and 2, 4 and 12 weeks from baseline