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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 10.1186/ISRCTN21694164
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym The NIFTY Trial (The Northern Ireland Fibromyalgia Therapy Trial)
Serial number at source PRF/02/3; 02/04
Study hypothesis To determine the effectiveness of conventional treatment and a combined education and pool-based exercise programme for patients recently diagnosed with fibromyalgia syndrome (FMS).
Lay summary
Ethics approval Ethics approval was granted prior to commencement of participant recruitment.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Fibromyalgia
Participants - 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
Participants - 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
Anticipated start date 01/03/2003
Anticipated end date 01/03/2006
Status of trial Completed
Patient information material
Target number of participants 156
Interventions 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 patientsí 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
Primary outcome measure(s) Fibromyalgia Impact Questionnaire.
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
Sources of funding Physiotherapy Research Foundation (UK) (ref: PRF/02/3)
Trial website
Publications Poster presentation: McVeigh JG, Hurley DA, Basford JR, Sim J, Baxter GD, Finch MB. A randomised controlled trial to evaluate the effectiveness of a combined education and pool-based exercise programme and usual care versus usual care in the treatment of patients with fibromyalgia syndrome. British Pain Society, Harrogate April 2006 - http://www.britishpainsociety.org/meet_pasasm.htm#2006

Abstract: McVeigh JG, Hurley DA, Basford JR, Sim J, Baxter GD, Finch MB. A randomised controlled trial to evaluate the effectiveness of a pool-based exercise and patient education programme plus usual medical care in the treatment of patients with fibromyalgia syndrome. Rehabilitation and Therapy Research Society Annual Conference, Dublin, Rep. of Ireland, May 2006 - http://www.rtrs.org/assets/PTR_abstracts.pdf

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 11, Number 3, September 2006, pp. 205-228(24) - http://www.ingentaconnect.com/content/maney/ptr/2006/00000011/00000003/art00009
Contact name Mr  Joseph  McVeigh
  Address School of Health Sciences
University of Ulster
Jordanstown
Newtownabbey
  City/town Belfast
  Zip/Postcode BT37 0QB
  Country United Kingdom
  Tel +44 (0)28 90368148
  Email j.mcveigh@ulster.ac.uk
Sponsor University of Ulster (UK)
  Address Joseph McVeigh
School of Health Sciences
University of Ulster
Jordanstown
Newtownabbey
  City/town Belfast
  Zip/Postcode BT37 0QB
  Country United Kingdom
  Tel +44 (0)28 90368148
  Email j.mcveigh@ulster.ac.uk
Date applied 12/09/2005
Last edited 16/06/2008
Date ISRCTN assigned 31/10/2005
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