Contact information
Type
Scientific
Primary contact
Mr Joseph McVeigh
ORCID ID
Contact details
School of Health Sciences
University of Ulster
Jordanstown
Newtownabbey
Belfast
BT37 0QB
United Kingdom
+44 (0)28 90368148
j.mcveigh@ulster.ac.uk
Additional identifiers
EudraCT number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PRF/02/3; 02/04
Study information
Scientific title
Acronym
The NIFTY Trial (The Northern Ireland Fibromyalgia Therapy Trial)
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).
Ethics approval
Ethics approval was granted prior to commencement of participant recruitment.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Fibromyalgia Impact Questionnaire.
Secondary outcome measures
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
Overall trial start date
01/03/2003
Overall trial end date
01/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
156
Participant 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
Recruitment start date
01/03/2003
Recruitment end date
01/03/2006
Locations
Countries of recruitment
Northern Ireland, United Kingdom
Trial participating centre
School of Health Sciences
Belfast
BT37 0QB
United Kingdom
Sponsor information
Organisation
University of Ulster (UK)
Sponsor details
Joseph McVeigh
School of Health Sciences
University of Ulster
Jordanstown
Newtownabbey
Belfast
BT37 0QB
Northern Ireland
United Kingdom
+44 (0)28 90368148
j.mcveigh@ulster.ac.uk
Sponsor type
University/education
Website
GRID
Funders
Funder type
Research organisation
Funder name
Physiotherapy Research Foundation (UK) (ref: PRF/02/3)
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
Individual participant data (IPD) sharing statement
Participant level data
Not provided at time of registration
Trial outputs
| 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 |