Chronic Low Back Pain (Non-specific, Uncomplicated)
Conditions
Keywords
pain education, patient-led goal setting, chronic low back pain
Brief summary
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.
Interventions
OTHERPain education and patient-led goal setting
8 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.
OTHERGuideline-based written advice
Participants 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.
Sponsors
Neuroscience Research Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * access to internet
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Week 26 post-randomisation | Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale |
| Disability | Week 26 post-randomisation | Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Weeks 8 and 52 post-randomisation | Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale |
| Disability | Weeks 8 and 52 post-randomisation | Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability |
| Pain self-efficacy | Weeks 8, 26 and 52 post-randomisation | Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy |
| Back beliefs | Weeks 8, 26 and 52 post-randomisation | 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 |
| Kinesiophobia | Weeks 8, 26 and 52 post-randomisation | Fear of movement (re)injury assessed by the short-form of the Tampa Scale of Kinesiophobia; scale range 4-16 (higher scores indicate greater kinesiophobia) |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Weeks 8, 26 and 52 post-randomisation | Health-Related Quality of Life assessed using the EQ-5D-5L dimensions scale range, 1-5; higher scores indicate better quality of life) and health thermometer (range, 0-100; higher scores indicate better quality of life). |
| Daily step count | Week 8 post-randomisation | Average daily step count over the past 7 days assessed using accelerometry. |
| Light intensity physical activity | Week 8 post-randomisation | Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry |
| Moderate-vigorous intensity physical activity | Week 8 post-randomisation | Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry |
| Sedentary time | Week 8 post-randomisation | Sedentary time (min/day) over the past 7 days assessed using accelerometry |
| Subjective physical activity levels | Weeks 8, 26 and 52 post-randomisation | Self-reported physical activity over the previous 7 days assessed using the short-form of the International Physical Activity Questionnaire (IPAQ) |
| Lifestyle risk factors | Weeks 8, 26 and 52 post-randomisation | Diet (do you eat less than two serves of fruit per day? (yes/no); do you eat less than fives serves of vegetables per day? (yes/no)). Alcohol intake (On average, how much alcohol do you drink each week? (I rarely/never drink alcohol; Less than 14 standard drinks; Between 14 and 21 standard drinks; More than 21 standard drinks) |
| Blood pressure | Week 8 post-randomisation | Blood pressure at rest assessed via an automated sphygmomanometer |
| Adverse events | From randomisation to Week 8 post-randomisation | Adverse events assessed via self-report |
| Adherence to treatment | From randomisation to Week 8 post-randomisation | Adherence to treatment assessed via session attendance and self-report (diary) |
| Total healthcare costs | Weeks 8, 26 and 52 post-randomisation | Total health-care costs will be estimated as the trial intervention costs and outside trial health-care resource use attributable to chronic low back pain from the Medicare Benefits Scheme and Pharmaceutical Benefits Scheme. Quality-adjusted life-years (QALYs) from the EQ-5D-5L using the Australian utility weights will also be used in the trial-based cost-utility analysis. |
| Goal attainment (goal setting arm only) | Weeks 8, 26 and 52 post-randomisation | Goal attainment assessed using the goal attainment scale. Each goal is rated on a 5-point scale: +2 = much more than expected, +1 = somewhat more than expected, 0 = Patient achieves the expected level, -1 = somewhat less than expected, -2 = much less than expected. |
Countries
Australia
Contacts
CONTACTMatthew D Jones
PRINCIPAL_INVESTIGATORMatthew D Jones
UNSW Sydney
Outcome results
None listed