Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuroscience Research Australia
About this trial
The goal of this clinical trial is to investigate the effectiveness of two treatments for adults with chronic low back pain. The main question this study seeks to answer is "In adults with chronic low back pain, what is the effectiveness of pain education and patient-led goal setting compared to guideline-based written advice on reducing pain intensity and disability?".
A total of 392 participants will be randomised into two groups: 1) pain education and patient-led goal setting or 2) guideline-based written advice. Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks delivered online via telehealth. Participants randomised to written advice group will receive information developed for people with chronic low back pain. Outcomes will be assessed at baseline and week 8, 26 and 52.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Low back pain of at least 3 months duration
physically inactive (less than or equal to 150min/week moderate intensity physical activity; 75 min/week vigorous activity, or some combination of the two)
no known contraindication(s) to performing physical activity
English language proficiency
Disqualifiers
physically active (more than 150min/week moderate intensity physical activity, 75 min/week vigorous activity, or some combination of the two)
known contraindication(s) to performing physical activity
known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder)
scheduled for major surgery during the treatment or follow-up period
Trial design
Design model
Parallel
Treatments tested in this trial
Pain education and patient-led goal setting
Other intervention8 week program delivered via five, up to 1-hour telehealth sessions. The sessions will be scheduled at approximately fortnightly intervals. Participants will also be prescribed approximately 30 minutes of online activities with each session. Pain education will be based on Explain Pain and the curriculum will have specified learning objectives adapted for each individual participant. Participants will access the online education curriculum through Pathwright. For patient-led goal setting, the healthcare practitioner will take an initial history of the participants physical activity behaviours and problems related to their back pain. The participant will prioritise their problems according to impact in their life. Strategies will then be discussed, and the participant will, in collaboration with the healthcare practitioner, set goals and strategies to work on independently between sessions.
Guideline-based written advice
Other interventionParticipants will receive guideline-based written information for the management of chronic low back pain. This will include information about the prognosis of low back pain and treatment options to consider.
Treatment groups
392 Participants
are divided into 2 treatment groupsGroup A: Pain education and patient-led goal settingExperimental treatment 1 intervention
Group B: Written adviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Time frame
Week 26 post-randomisation2
Disability
Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
Time frame
Week 26 post-randomisationSecondary outcomes
1
Pain intensity
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Time frame
Weeks 8 and 52 post-randomisation2
Disability
Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
Time frame
Weeks 8 and 52 post-randomisation3
Pain self-efficacy
Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy
Time frame
Weeks 8, 26 and 52 post-randomisation4
Back beliefs
Back beliefs assessed using the Back Beliefs Questionnaire (BBQ); scale range 9-45, lower scores indicate more pessimistic beliefs about the consequences of low back pain
Time frame
Weeks 8, 26 and 52 post-randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov