Skip to main content

Research Repository

Advanced Search

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)

Clarke, Carl E.; Patel, Smitaa; Ives, Natalie; Rick, Caroline E.; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F.; Zhu, Shihua; Kandiyali, Rebecca; Yao, Guiqing; Sackley, Catherine M.

Authors

Carl E. Clarke

Smitaa Patel

Natalie Ives

Rebecca Woolley

Keith Wheatley

Marion F. Walker

Shihua Zhu

Rebecca Kandiyali

Guiqing Yao

Catherine M. Sackley



Abstract

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 showed no difference in NEADL total score, but PDQ-39 summary index (curves diverging at 1.6 points per annum, 95% CI 0.47 to 2.62; p = 0.005) and EQ-5D quotient (0.02, 95% CI 0.00007 to 0.03; p = 0.04) showed significant but small differences in favour of the therapy arm. Cost-effective analysis showed that therapy was associated with a slight but not significant gain in quality-adjusted life-years (0.027, 95% CI –0.010 to 0.065) at a small incremental cost (£164, 95% CI –£141 to £468), resulting in an incremental cost-effectiveness ratio of under £4000 (£3493, 95% –£169,371 to £176,358). There was no difference in adverse events or serious adverse events.
Conclusions

NHS PT and OT did not produce immediate or long-term clinically meaningful improvements in ADL or quality of life in patients with mild to moderate Parkinson’s disease. This evidence does not support the use of low-dose, patient-centred, goal-directed PT and OT in patients in the early stages of Parkinson’s disease. Future research should include the development and testing of more structured and intensive PT and OT programmes in patients with all stages of Parkinson’s disease.

Citation

Clarke, C. E., Patel, S., Ives, N., Rick, C. E., Woolley, R., Wheatley, K., …Sackley, C. M. (2016). 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). Health Technology Assessment, 20(63), https://doi.org/10.3310/hta20630

Journal Article Type Article
Acceptance Date Aug 1, 2016
Publication Date Aug 1, 2016
Deposit Date Oct 27, 2016
Publicly Available Date Oct 27, 2016
Journal Health Technology Assessment
Print ISSN 1366-5278
Electronic ISSN 1366-5278
Publisher NIHR Journals Library
Peer Reviewed Peer Reviewed
Volume 20
Issue 63
DOI https://doi.org/10.3310/hta20630
Public URL http://eprints.nottingham.ac.uk/id/eprint/38008
Publisher URL http://www.journalslibrary.nihr.ac.uk/hta/volume-20/issue-63#abstract
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf

Files


117 PD Rehab FullReport-hta20630 August 2016.pdf (1.7 Mb)
PDF

Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





You might also like



Downloadable Citations