None listed
Conditions
Brief summary
Low back pain that persists for longer than 6 months is an expensive and troublesome problem for individuals and society. In this randomised controlled trial, volunteers with persistent low back or leg pain (> 6 months duration) will all receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions (over a 6-month period) and complete outcome questionnaires over a 12-month period. The trial compares two different physiotherapy treatment approaches. Participants will not know what the two treatment approaches are, and they will not know the study hypothesis. Treating physiotherapists will not know what treatment participants in the other group are receiving, Information about the two treatment approaches has therefore been withheld from the registry to maintain blinding, but full details have been uploaded to the registry and will be released at the conclusion of the trial.
Interventions
Physiotherapy treatment A. Participants will receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions over a 6-month period. All participants will be treated by qualified and registered physiotherapists at one of four private physiotherapy clinics throughout Melbourne, Australia. To protect trial blinding, the nature of the physiotherapy treatment is being withheld from the registry but has been provided privately to ANZCTR staff and will be made public
Physiotherapy treatment A. Participants will receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions over a 6-month period. All participants will be treated by qualified and registered physiotherapists at one of four private physiotherapy clinics throughout Melbourne, Australia. To protect trial blinding, the nature of the physiotherapy treatment is being withheld from the registry but has been provided privately to ANZCTR staff and will be made publically available at the conclusion of the trial. Treatment fidelity will be monitored by the submission of the physiotherapist's treatment notes to the researchers for every patient.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
i) A primary complaint of either low back pain or back-related leg pain ii) Duration of current episode of at least 6 months iii) Aged between 18 and 65 years iv) Sufficient fluency in English to complete outcome questionnaires
Exclusion criteria
i) Red flag pathologies (active cancer, signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging, risk of spinal fracture, signs of potential infection, foot drop that may cause tripping, spondyloarthropathy) ii) A compensation claim for low back pain iii) Pregnancy or childbirth within the last 6 months iv) Spinal injections within the last 6 weeks v) Any history of lumbar spine surgery, including for insertion of spinal cord stimulators vi) A pain score of less than 2/10 on a numerical rating scale, or an activity limitation score < 20% (measure with the Oswestry) vii) Already received physiotherapy treatment for low back pain at one of the involved treatment centres within the last 2 years viii) A presentation that makes the participant unsuitable for single-discipline physiotherapy treatment (ie. the patient is likely to require complex medical and / or psychological care beyond what physiotherapy can offer): a. Dependent on >20mg per day of Morphine equivalent Opioid medication over the last month b. Likely post-traumatic stress disorder, determined by a score of 43 or more on the PTSD Checklist (civilian version: PCL-C) c. Extremely severe depression, determined by a score of 14 or more on the depression section of the Depression and Anxiety Scales (DASS-21)
Outcome results
None listed