|
ISRCTN
|
ISRCTN66190737
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Facilitating Activity and Self management in Arthritis (FASA)
|
|
Scientific title
|
Exercise and self-management for people with chronic knee, hip or lower back pain: a study of clinical and cost effectiveness
|
|
Acronym
|
FASA
|
|
Serial number at source
|
UWE CE10/0817
|
|
Study hypothesis
|
1. To determine whether a generic exercise and self-management intervention delivered to groups of patients with chronic knee, hip or lower back pain can improve function six months post-completion of the intervention
2. To evaluate the acceptability and adherence to the intervention and determine professionals perspectives regarding the intervention
3. To determine the cost-effectiveness of the intervention compared to continued general practitioner (GP) care at six months post-completion of the intervention
|
|
Lay summary
|
Lay summary under review
|
|
Ethics approval
|
National Research Ethics Service, South West - Southmead approved on 7 July 2011, ref: 11/SW/0053
|
|
Study design
|
Cluster randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Chronic musculoskeletal pain and osteoarhritis
|
|
Participants - inclusion criteria
|
1. Aged over 50 years with joint dysfunction
2. Those who have consulted a primary care physician for chronic musculoskeletal degenerative pain of the lower back, hip or knee of at least 6 months duration
|
|
Participants - exclusion criteria
|
1. Lower limb arthroplasty
2. Physiotherapy for associated condition in the preceding 12 months
3. Unstable medical conditions
4. Inability/unwillingness to exercise
5. Wheelchair dependence
6. Non-English speaking (due to pragmatic reasons of cost and engagement with the group intervention)
|
|
Anticipated start date
|
01/12/2011
|
|
Anticipated end date
|
30/11/2014
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
352
|
|
Interventions
|
Participants allocated to the intervention arm will receive 6-weeks (twice weekly) group exercise (approximately 8 participants) and self-management based on the ESCAPE programme. In brief, each session lasts for 60-minutes and includes 15-20 minutes of physiotherapist led group discussion and problem-solving session (with supporting handouts) regarding issues of self-management. Topics include activity-rest cycling, use of ice and heat for pain relief, goal-setting and action plans, exercise recommendations and healthy eating and managing changes in pain. After each discussion, participants undertake 35-40 minutes of exercise, based on a circuit of strengthening, aerobic and co-ordination activities. Further to the exercise circuit, in collaboration with the physiotherapist each individual completes an action plan regarding exercise/activities they want to achieve over the following week. This is reviewed after each week, to determine adherence to plan, problem-solving if the goal has proved unachievable, or progressed if achieved. All interventions will be conducted in physiotherapy departments of community/primary care hospitals in Wiltshire. Participants allocated to the continued GP care (control) arm are permitted to continue any current pharmacological or non-pharmacological treatment strategies; furthermore they can be referred for any treatments in primary or secondary care.
Participants will be assessed at baseline, post-intervention and six months later (primary end point)
|
|
Primary outcome measure(s)
|
Short musculoskeletal functional assessment
|
|
Secondary outcome measure(s)
|
1. Self-efficacy and exercise health beliefs questionnaire
2. Hospital Anxiety and Depression scale
3. Short Form McGill Pain questionnaire
4. Aggregated Functional Performance Time (AFPT) a combined measure of walking, stair ascent and descent
5. Blood pressure
6. Weight and hip to waist ratio
7. EuroQol EQ-5D self-report generic health status measure (for health related quality of life, and to allow estimation of Quality Adjusted Life Years)
8. Self-reported resource use, (using the framework of the Client Services Receipts Inventory (CSRI) which collects self-reported data across a wide range of items including primary care, hospital care, use of rehabilitation facilities and patient costs)
|
|
Sources of funding
|
Chartered Society of Physiotherapy Charitable Trust (UK) (ref: PEP-2010)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Nicola
Walsh
|
|
Address
|
Faculty of Health and Life Sciences (HLS)
Glenside Campus
Blackberry Hill
Stapleton
|
|
City/town
|
Brsitol
|
|
Zip/Postcode
|
BS16 1DD
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)117 328 8534
|
|
Fax
|
+44 (0)117 328 8418
|
|
Email
|
nicola.walsh@uwe.ac.uk
|
|
Sponsor
|
University of the West of England (UK)
|
|
Address
|
UWE Bristol
Coldharbour Lane
|
|
City/town
|
Bristol
|
|
Zip/Postcode
|
BS16 1QY
|
|
Country
|
United Kingdom
|
|
Email
|
robin.means@uwe.ac.uk
|
|
Sponsor website:
|
http://www.uwe.ac.uk/
|
|
Date applied
|
26/10/2011
|
|
Last edited
|
24/11/2011
|
|
Date ISRCTN assigned
|
24/11/2011
|
