None listed
Conditions
Brief summary
Manual therapy is an effective intervention for treatment of people with knee osteoarthritis (OA). However, the optimal treatment dose has yet to be defined. Dose is a well-recognised aspect of any treatment approach and is known to affect clinical outcomes. For example in the fields of medication or radiation therapy it would be unheard of not to prescribe a dose of treatment. Surprisingly, it has been scarcely investigated for manual therapy. Existing studies of manual therapy for knee OA show many differences in the frequency of treatment, varying from once to twice or three times per week. There are no rationales provided in any previous studies for the selection of treatment frequency, which may be due to uncertainty about the mechanisms of action of manual therapy. Variation in provision of treatment makes it difficult to directly compare results from different studies, or for physiotherapists to translate findings into clinical practice. Therefore there is a clear need for research to investigate the optimal dose of manual therapy for people with knee OA. This research will investigate whether frequency of treatment with manual therapy for people with knee OA affects clinical outcomes at 6-month follow-up. In a fully-powered, 3-arm, clinical randomised controlled trial (RCT), participants receiving six manual therapy treatments at a frequency of twice per week will be compared to those receiving six treatments at a frequency of once per week, compared to a control group with best-practice usual care. Furthermore an economic analysis will evaluate if the interventions are cost-effective and value for money. Findings from the OPTi-OK (Optimisation of Physiotherapy Treatment in Knee Osteoarthritis) RCT will provide practical information about delivery of care that will promote rapid translation into physiotherapy practice.
Interventions
Arm 1: Manual therapy involving passive accessory movements, passive physiological movements, and mobilisations with movement, applied to the tibio-femoral, patello-femoral and superior tibio-fibular joints. Forces applied and number of repetitions will be decided by the physiotherapist, aiming to alter joint structures while accounting for the tolerance of individual participants. The pain response of the participant will guide these decisions. At the final (sixth) treatment session every parti
Arm 1: Manual therapy involving passive accessory movements, passive physiological movements, and mobilisations with movement, applied to the tibio-femoral, patello-femoral and superior tibio-fibular joints. Forces applied and number of repetitions will be decided by the physiotherapist, aiming to alter joint structures while accounting for the tolerance of individual participants. The pain response of the participant will guide these decisions. At the final (sixth) treatment session every participant will receive exercise therapy, advice and education on managing their osteoarthritis. A multi-modal exercise programme including range of motion, strengthening, aerobic and co-ordination exercises,will be individually tailored to each participant using variations in amount of resistance, and number of exercise repetitions. The aim is to challenge the participant and fatigue the muscles, in order to produce a treatment effect. The exercise programme and education/advice will also be provided in written format. The treatment will be provided by New Zealand registered physiotherapists, at a frequency of twice per week for three weeks. Each session will be of 45 minutes duration. The intervention will be provided in University Physiotherapy Clinics or Physiotherapy Private Practices. Arm 2: As for Arm 1 but provided at a frequency of once per week for six weeks. Each session will be of 45 minutes duration. Adherence to compliance with the allocated treatment frequency will be reported by reviewing the electronic attendance record. Fidelity to treatment protocols will be monitored by random audit of participant notes, and observation of at least two treatment sessions per trial physiotherapist, conducted by the Primary Investigator (CC).
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (45yrs or older) with persistent knee pain (pain on most days in the last month) Clinical classification criteria for knee OA (American College of Rheumatology): persistent knee pain plus 3 of the following: morning knee stiffness that eases within 30 mins; no heat/effusion; bony enlargement; pain on palpation; crepitus; age 50 years or over. In addition, the nominated knee must lack full extension (at least 5 degrees loss of movement).
Exclusion criteria
Previous lower limb joint arthroplasty, lower limb surgery in previous 12 months, significant injury (requiring medical specialist treatment) to lower limb in previous 12 months, a course of conservative management for knee OA in previous 12 months, consultation with orthopaedic/rheumatology specialist for OA, on waiting list for knee surgery, commencement of new medication for OA (previous 1 month); knee joint injection in previous 3 months; other forms of arthritis particularly inflammatory disease such as rheumatoid arthritis, plus comorbidities that will preclude safe application of manual or exercise therapy e.g. severe osteoporosis, uncontrolled hypertension.
Outcome results
None listed