Clinical effectiveness and cost-effectiveness of physiotherapy and occupational therapy versus no therapy in mild to moderate Parkinson’s disease: a large pragmatic randomised controlled trial (PD REHAB)

Background Cochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson’s disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up. Objectives To evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson’s disease. Design Large pragmatic randomised controlled trial. Setting Thirty-eight neurology and geriatric medicine outpatient clinics in the UK. Participants Seven hundred and sixty-two patients with mild to moderate Parkinson’s disease reporting limitations in activities of daily living (ADL). Intervention Patients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting. Main outcome measures The primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson’s Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation. Results Data from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) –0.7 to 1.7; p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI –1.5 to 1.5; p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (–0.03, 95% CI –0.07 to –0.002; p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis including all time points s