Condition category
Musculoskeletal Diseases
Date applied
26/10/2011
Date assigned
24/11/2011
Last edited
16/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
As the population increases and people live longer, diseases associated with older age pose a considerable public health issue. Demands on already compromised health services are likely to grow as individuals seek medical assistance to retain independence and quality of life. The pressure on the older individual to remain healthy will intensify in association with the expectations to continue working into the seventh decade. Chronic joint pain including osteoarthritis (OA) can significantly limit the functional independence of individuals, and given that 25% of the population experience these problems, the impact is immense. These conditions are not life-threatening, but the effects of pain, immobility and reduced function can contribute to the development and progression of other serious conditions common in the older population. Furthermore associated anxiety and depression is recognisably higher in this group; reducing the impact of these conditions is key to maintaining a healthy older population.
Although chronic musculoskeletal pain and OA can present in any joint, the hip, knee and back are mainly affected. There is good evidence that exercise reduces pain and improves function in patients with chronic joint pain, but in order to encourage exercise participation, patients require appropriate advice, instruction and facilities. Approximately 70% of GPs reportedly recommend exercise for these conditions, whilst one third of those affected are reportedly referred for physiotherapy.
Adherence to exercise like any healthcare intervention is generally poor, most patients stop exercising once formal programmes cease as a result of loss of interest, time commitment, minimal change in function and availability of facilities. Symptoms often return and re-referral for further treatment is common at considerable cost to health services.
However, previous work from our group has demonstrated that for chronic knee pain/OA, a six-week exercise and self-management intervention (called ESCAPE) facilitated by a physiotherapist resulted in significant improvements in function and pain six-months after rehabilitation ceased; furthermore, participants still showed improvements 2½ years later. In addition, this intervention was cost-effective compared to usual GP care.
Most studies tailor interventions for specific joints e.g. hip or knee. In order to deliver evidence-based treatments this therefore requires clinicians to either manage patients on an individual basis or refer to joint specific group interventions. Neither option is ideal – the first results in significant time and financial cost, whilst the second often requires patients to wait for appropriate numbers of people to be referred to allow groups to run. Additionally, many older people with degenerative joint problems experience pain and functional difficulty in other joints, seeking further healthcare input when these present.
This research will help us to determine whether an exercise and self-management intervention delivered to groups of patients with chronic knee, hip or lower back pain can improve function six months after completion of the intervention; whether this works better than continued GP care.

Who can participate?
Participants will be recruited from GP practices in Wiltshire Primary Care Trust (UK). Individuals ages 50 years or older who have consulted their GP for ongoing joint pain of the lower back, hip or knee of at least 6 months duration.

What does the study involve?
GP practices will be randomly allocated to one of two groups: the GP practices'’ participants receive exercise and SM or remain on continued GP care (control arm). On completion of the exercise class, and six months later we will measure any changes in pain, function, willingness to exercise, confidence and anxiety and depression, to see whether the classes have benefited people.

What are the possible benefits and risks of participating?
Patients will be provided with providing general self-management skills that can be used for managing problems in lower limb joints or the lower back through exercise. This could potentially reduce the need for repeat visits to healthcare professionals as advice is frequently the same for many presentations. In addition, widening therapy to cover patients with more than one joint affected would attract more patients and enable classes to run more frequently, thus reducing waiting times. Encouraging individuals to pursue regular exercise and activity has the added potential to improve general health status in addition to joint function. Improving weight and blood pressure can reduce the risk of developing other conditions which are prevalent in this age group.

Where is the study run from?
GP practices in Wiltshire Primary Care Trust (UK)

When is the study starting and how long is it expected to run for?
December 2011 to November 2014

Who is funding the study?
This study is funded by the Charitable Trust of the Chartered Society of Physiotherapy and sponsored by the University of the West of England, Bristol (UK).

Who is the main contact?
Dr Nicola Walsh
Nicola.walsh@uwe.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicola Walsh

ORCID ID

Contact details

Faculty of Health and Life Sciences (HLS)
Glenside Campus
Blackberry Hill
Stapleton
Bristol
BS16 1DD
United Kingdom
+44 (0)117 328 8534
nicola.walsh@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UWE CE10/0817

Study information

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

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

Ethics approval

National Research Ethics Service, South West - Southmead, 07/07/2011, ref: 11/SW/0053

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Chronic musculoskeletal pain and osteoarhritis

Intervention

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)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Short musculoskeletal functional assessment

Secondary outcome measures

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)

Overall trial start date

01/12/2011

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

352

Participant 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)

Recruitment start date

01/12/2011

Recruitment end date

30/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Health and Life Sciences (HLS)
Brsitol
BS16 1DD
United Kingdom

Sponsor information

Organisation

University of the West of England (UK)

Sponsor details

UWE Bristol
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
-
robin.means@uwe.ac.uk

Sponsor type

University/education

Website

http://www.uwe.ac.uk/

Funders

Funder type

Charity

Funder name

Chartered Society of Physiotherapy Charitable Trust (UK) (ref: PEP-2010)

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

Publication citations

Additional files

Editorial Notes

16/11/2016: No publications found, verifying study status with principal investigator.