None listed
Conditions
Brief summary
The study design is a comparative effectiveness clinical trial with participants acting as their own controls. The research question is to establish if massage therapy in addition to standard care for chronic low back pain improves clinical and cost effectiveness outcomes compared to standard care alone. Standard care is defined as whatever the participant did for their low back pain over the month preceding recruitment and their first massage treatment for the low back pain and will be assessed retrospectively. Clinical and cost effectiveness will be assessed using validated patient reported outcome measures (PROMs) and case reports to be completed at recruitment and again after each month of treatment for the prospective two month treatment phase plus one month of follow-up (three months total study duration per participant). In addition, participant diaries for recording symptoms, medication and any adverse events experienced over each month will be distributed at recruitment and collected at each subsequent data collection point. Massage treatment will be determined by the participating massage therapists who will be recruited through the Practitioner Research and Collaboration Initiative (PRACI) and registered with an appropriate professional body. Participating therapists will screen potential clients for inclusion and obtain consent. The primary research objective will be to substantiate the clinical and cost effectiveness of massage plus standard care for the treatment of chronic low back pain compared to standard care. If this study shows clinical and cost benefits from adjunctive massage therapy it has the potential to enhance clinical management and improve health outcomes for patients with chronic low back pain in Australia and internationally.
Interventions
Massage therapy plus usual treatment for chronic low back pain over two months plus one extra month of follow-up. Massage therapists will be recruited from the Practitioner Research and Collaboration Initiative (PRACI) database and will be qualified massage practitioners with professional association membership and Professional Indemnity Insurance. Consenting therapists will screen prospective clients for inclusion in the study. The massage therapy treatment will be remedial therapy administered
Massage therapy plus usual treatment for chronic low back pain over two months plus one extra month of follow-up. Massage therapists will be recruited from the Practitioner Research and Collaboration Initiative (PRACI) database and will be qualified massage practitioners with professional association membership and Professional Indemnity Insurance. Consenting therapists will screen prospective clients for inclusion in the study. The massage therapy treatment will be remedial therapy administered at the practitioner's discretion over at least two months of treatment. Treatment duration is anticipated to be 45 minutes to one hour. Treatment frequency will be determined by the massage therapist but it is anticipated to be once per week to once per fortnight. The treatment will take place at the massage therapist's own clinic. All other treatments, including those from other manual therapists, will be recorded in the Participant Diary each week by the participant and this will be included in "usual treatment". No strategies will be used to improve adherence other than those used by the therapist in their normal clinical practice. Usual treatment is defined as any treatment the participant uses for chronic low back pain other than the massage treatment provided by the participating massage therapist.
Sponsors
Endeavour College of Natural Health Office of Research
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Between the age of 18 and 80 years old 2. No massage for low back pain previously from a qualified, registered massage therapist 3. Grade 1 or higher on the Modified Graded Chronic Pain Scale 4. Chronic low back pain for longer than 6 months
Exclusion criteria
Disclaimer: The Key exclusion criteria is based on standard recommendations to avoid massage. The massage therapist is to decide if they would normally conduct massage on the participant or not. 1. Any person who is unable to read, understand or acknowledge what it means to be in the study. 2. A person with open wounds on the back including cuts, lacerations or grazes 3. Diagnosed muscle or tendon tears, partial tears or ruptures around the back or buttocks 4. A person with contusions on the back or buttocks 5. A person with burns, chilblains or broken bones. 6. Diagnosed periostitis or bursitis 7. A person with infections of the skin or soft tissue on their back 8. Diagnosed with haemophilia 9. A person with a solid tumour on their back or abdomen
Outcome results
None listed