A randomised controlled trial to evaluate the effectiveness of a combined education and pool-based exercise programme and usual care in the treatment of patients with fibromyalgia syndrome

ISRCTN	ISRCTN21694164
DOI	https://doi.org/10.1186/ISRCTN21694164
Protocol serial number	PRF/02/3; 02/04
Sponsor	University of Ulster (UK)
Funder	Physiotherapy Research Foundation (UK) (ref: PRF/02/3)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Joseph McVeigh
Scientific

School of Health Sciences
University of Ulster
Jordanstown
Newtownabbey
Belfast
BT37 0QB
United Kingdom

Phone	+44 (0)28 90368148
Email	j.mcveigh@ulster.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The NIFTY Trial (The Northern Ireland Fibromyalgia Therapy Trial)
Study objectives	To determine the effectiveness of conventional treatment and a combined education and pool-based exercise programme for patients recently diagnosed with fibromyalgia syndrome (FMS).
Ethics approval(s)	Ethics approval was granted prior to commencement of participant recruitment.
Health condition(s) or problem(s) studied	Fibromyalgia
Intervention	Intervention Group: Patients allocated to the intervention group will receive a package of treatment consisting of: 1. A series of lecturers/workshops aimed at addressing patients attitudes, beliefs and behaviours with respect to FMS 2. A 6 week programme of pool-based aerobic exercises The education and exercise interventions will be provided by suitably qualified and experienced occupational therapists and physiotherapists. Control: Usual care
Intervention type	Other
Primary outcome measure(s)	Fibromyalgia Impact Questionnaire.
Key secondary outcome measure(s)	1. Tender point count and Total myalgic score 2. The 6-minute walk test 3. The Arthritis Impact Measurement Scales II (AIMS2) 4. McGill Pain Questionnaire
Completion date	01/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	156
Key inclusion criteria	1. Women between the ages of 18 and 65 years. (If of childbearing age, state that they are not pregnant.) 2. Fulfil the 1990 American College of Rheumatology diagnostic criteria for fibromyalgia (i.e. at least a 3-month history of widespread pain in conjunction with tenderness at 11 of 18 specific tender points) 3. Able to attend and participate in a 6 week programme of moderate intensity exercise in a hydrotherapy pool 4. Diagnosed by a consultant rheumatologist with FMS within the previous 3 months 5. Give written informed consent to take part in the trial 6. Literate
Key exclusion criteria	1. Have concomitant medical illness (e.g. ischaemic heart disease, cerebrovascular accident) that would make participation in an exercise class unsafe 2. Are involved in ongoing litigation involving FMS 3. Score of less than 3 on a 10-point visual analogue scale (VAS) for pain (a low level cut off will avoid floor effects) 4. Have received physiotherapy within the last 3 months for FMS
Date of first enrolment	01/03/2003
Date of final enrolment	01/03/2006

School of Health Sciences

Belfast
BT37 0QB
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	Abstract: McVeigh JG, Hurley DA, Basford JR, Sim J, Baxter GD, Finch MB Effectiveness of a combined pool-based exercise and education programme compared to usual medical care in fibromyalgia syndrome: a randomised, controlled trial. Physical Therapy Reviews, Volume , Number 3, September 2006, pp. 205-228(24) -	01/06/2006		No	No