A factorial randomized controlled trial.
To investigate the addition of manual therapy to exercise therapy for the reduction of pain and increase of physical function in people with knee osteoarthritis (OA), and whether "booster sessions" compared to consecutive sessions may improve outcomes.
The benefits of providing manual therapy in addition to exercise therapy, or of distributing treatment sessions over time using periodic booster sessions, in people with knee OA are not well established.
All participants had knee OA and were provided 12 sessions of multimodal exercise therapy supervised by a physical therapist. Participants were randomly allocated to 1 of 4 groups: exercise therapy in consecutive sessions, exercise therapy distributed over a year using booster sessions, exercise therapy plus manual therapy without booster sessions, and exercise therapy plus manual therapy with booster sessions. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score; 0-240 scale) at 1-year follow-up. Secondary outcome measures were the numeric pain-rating scale and physical performance tests.
Of 75 participants recruited, 66 (88%) were retained at 1-year follow-up. Factorial analysis of covariance of the main effects showed significant benefit from booster sessions (P = .009) and manual therapy (P = .023) over exercise therapy alone. Group analysis showed that exercise therapy with booster sessions (WOMAC score, -46.0 points; 95% confidence interval [CI]: -80.0, -12.0) and exercise therapy plus manual therapy (WOMAC score, -37.5 points; 95% CI: -69.7, -5.5) had superior effects compared with exercise therapy alone. The combined strategy of exercise therapy plus manual therapy with booster sessions was not superior to exercise therapy alone.
Distributing 12 sessions of exercise therapy over a year in the form of booster sessions was more effective than providing 12 consecutive exercise therapy sessions. Providing manual therapy in addition to exercise therapy improved treatment effectiveness compared to providing 12 consecutive exercise therapy sessions alone. Trial registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000460808).