Plain English Summary

Not provided at time of registration

Trial website

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

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 patientsÂ’ 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 measures

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

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

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
United Kingdom
+44 (0)28 90368148
j.mcveigh@ulster.ac.uk

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

Editorial Notes