Condition category
Musculoskeletal Diseases
Date applied
06/11/2006
Date assigned
30/04/2007
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sally Jessep

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PRF/03/03

Study information

Scientific title

Acronym

7OAKS-ESCAPE

Study hypothesis

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

The study was approved by the Maidstone & Tunbridge Wells Local Ethics Committee on the 18th December 2003 (ref: 149/9/03).

Study design

The trial is a pragmatic, randomised, single blind study and a pilot for a potentially larger project.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Western Ontario and McMasters Universities Osteoarthritic Index (WOMAC) functional score at 12 months.

Secondary outcome measures

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

Overall trial start date

01/03/2004

Overall trial end date

01/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 50 years of age
2. Presented to their General Practitioner with chronic knee pain

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

01/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy Department
Sevenoaks
TN13 3PG
United Kingdom

Sponsor information

Organisation

Physiotherapy Research Foundation (UK)

Sponsor details

Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom

Sponsor type

Research organisation

Website

http://www.csp.org.uk

Funders

Funder type

Research organisation

Funder name

Physiotherapy Research Foundation (UK) (ref. PRF/03/3)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19627690

Publication citations

  1. Results

    Jessep SA, Walsh NE, Ratcliffe J, Hurley MV, Long-term clinical benefits and costs of an integrated rehabilitation programme compared with outpatient physiotherapy for chronic knee pain., Physiotherapy, 2009, 95, 2, 94-102, doi: 10.1016/j.physio.2009.01.005.

Additional files

Editorial Notes