Improving rehabilitation for patients with chronic knee pain

ISRCTN	ISRCTN63848242
DOI	https://doi.org/10.1186/ISRCTN63848242
Protocol serial number	PRF/03/03
Sponsor	Physiotherapy Research Foundation (UK)
Funder	Physiotherapy Research Foundation (UK) (ref. PRF/03/3)

Submission date: 06/11/2006
Registration date: 30/04/2007
Last edited: 11/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Sally Jessep
Scientific

Physiotherapy Department
Sevenoaks Hospital
Hospital Road
Sevenoaks
TN13 3PG
United Kingdom

Study information

Primary study design	Interventional
Study design	The trial is a pragmatic, randomised, single blind study and a pilot for a potentially larger project.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	7OAKS-ESCAPE
Study objectives	1. For patients with chronic knee pain a rehabilitation regimen delivered in the community with regular follow-up reduces pain and disability better than routine physiotherapy and these benefits are maintained over time 2. The rehabilitation regimen reduces healthcare utilisation and is ultimately less costly than routine physiotherapy
Ethics approval(s)	The study was approved by the Maidstone & Tunbridge Wells Local Ethics Committee on the 18th December 2003 (ref: 149/9/03).
Health condition(s) or problem(s) studied	Chronic knee pain, osteoarthritis
Intervention	Interventions: Group one: Innovative exercise and education programme - this is a course of ten sessions each consisting of some education and some exercise Group two: Routine physiotherapy Outcome evaluation: Outcome measures at baseline and at 12-month follow-up assessment will be summarised using appropriate descriptive statistics. Primary analyses will be by intention-to treat. The level of significance will be set at p<0.05. The effect of the intervention on the Western Ontario and McMasters Universities Osteoarthritic Index (WOMAC) functional score will be assessed, first, by investigating whether outcomes differ significantly overall by groups. These analyses will be adjusted for baseline measures. The following additional analyses are planned. Two tests of interaction will be carried out to investigate whether the effect intervention is influenced by: 1. Depression (Hospital Anxiety and Depression [HAD] score), or 2. Self-efficacy (Arthritis Self-Efficacy Score) For all outcomes, both unadjusted (adjusting only for the baseline measure) and adjusted analyses (adjusting for other potential confounding factors) will be carried out; the latter will be interpreted as 'sensitivity analyses' to explore the robustness of the unadjusted analyses to possible confounding. Finally, process variables characterising the success with which the intervention was delivered (e.g. compliance) will be included in analyses of WOMAC functional score only, in order to interpret better the overall effects of the intervention. Economic evaluation: The primary economic evaluation will be a cost-effectiveness analysis comparing changes in the primary outcome (WOMAC) and total societal costs for each group. The secondary economic evaluation will be a cost-utility analysis based on utility weights associated with EuroQoL Health Survey (EQ-5D) health states. Cost-effectiveness acceptability curves will be employed for both the cost-effectiveness and cost-utility analyses in order to better inform decisions about the relative cost-effectiveness of the three treatments. Supplementary evaluation will take the form of a cost-consequences analysis, examining total and component costs alongside all outcomes. The data analyses would be conducted in a manner consistent with those employed in the clinical evaluation (for example, on an intention-to-treat basis, and adopting the same conventions with respect to cluster randomisation, missing items scores, missing observations etc.). Cost differences between groups will be tested using the student's t-test. Cost data are often skewed, violating the normality assumption underpinning the validity of the t-test. If this is the case, bootstrap replications of the original data will be performed to check the robustness of the t-test results. Sensitivity analyses will be performed to check the assumptions made in the cost calculations and analyses. In addition, the EuroQoL will enable calculation of cost per Quality Adjusted Life Year (QALY) for the interventions.
Intervention type	Other
Primary outcome measure(s)	Western Ontario and McMasters Universities Osteoarthritic Index (WOMAC) functional score at 12 months.
Key secondary outcome measure(s)	1. Aggregate Functional Performance Test (AFPT) 2. Health-related quality of life using the Euroquol 3. Exercise self-efficacy 4. Depression using the Hospital Anxiety and Depression scale
Completion date	01/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	1. Over 50 years of age 2. Presented to their General Practitioner with chronic knee pain
Key exclusion criteria	1. Unstable, co-existing medical or psychological conditions 2. Those treated with physiotherapy to the knee in the previous 12 months 3. Those receiving an intra-articular injection to the knee in the previous six months 4. Other joint pain that would prevent them participating in an exercise programme 5. Taking steroids 6. Wheelchair bound 7. A poor command of English
Date of first enrolment	01/03/2004
Date of final enrolment	01/03/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Physiotherapy Department

Sevenoaks
TN13 3PG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No