Frequency of manual therapy for individuals with knee osteoarthritis: The Opti-OK Trial

INTERVENTION: 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). CONDITION: Knee osteoarthritis; ; Knee osteoarthritis Musculoskeletal ‐ Osteoarthritis PRIMARY OUTCOME: Function using the function/daily living subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS)[4‐weeks and 7‐weeks after intervention starts, and 6‐months (primary timepoint) from randomisation] 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). SECONDARY OUTCOME: Costs and resource use will be collected using a costs questionnaire, which incorporates the Osteoarthritis Costs and Consequences Questionnaire (OCC‐Q) and the EQ‐5D‐5L[6‐months from randomisation] For Arms 1 and 2: Participant rated need for further treatment, with question "If you were not enrolled in this clinical trial, would you consider your knee good enough to be discharged from physiotherapy?"[At each follow‐up treatment session (5 times)] For Arms 1 and 2: Physiotherapist rated need for further treatment with the question ""If the participant was not enrolled in this clinical trial, would you consider their knee good enough to be discharged from physiotherapy?"[At each follow‐up treatment session (5 times)] Knee pain using the pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS)[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation] Knee range of motion measured with a goniometer[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation] Participant global; rating of change (GROC)[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation] Physical performance measure (PPM) 30‐second sit‐to‐stand[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation] PPM ‐ a timed 40 metre self‐paced walk[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation] PPM ‐ timed stair climb[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation] Quality of life using the EuroQOL (EQ‐5D‐5L)[6‐months from randomisation] Quality of life using the quality of life subscale of the KOOS[4‐weeks and 7‐weeks after intervention starts, and 6‐months from randomisation]