Clinical trial NCT06218459: A Comparison of Two Brief Interventions for People with Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic Pain
Feasibility Study
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: Norton Physiotherapy
name: Newcastle University
First posted: 2024-01-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential randomised assignment to intervention or control arms.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 0-10 Numeric Rating Scale for Pain Intensity
timeFrame: Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.
measure: The Roland Morris Disability Questionnaire
timeFrame: Change measures at five time points, baseline, 1 week and 2, 4 and 12 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Norton
country: United Kingdom
facility: Norton Physiotherapy Centre
state: Stockton-on-Tees
Study officials:
affiliation: Teesside University
name: Alasdair MacSween, PhD
role: PRINCIPAL_INVESTIGATOR
References: