Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
07/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ade Adebajo

ORCID ID

Contact details

Dept of Rheumatology
Barnsley District General Hospital
Gawber Road
Barnsley
S75 2EP
United Kingdom
+44 01226 777867
a.o.adebajo@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0034178702

Study information

Scientific title

Acronym

Study hypothesis

Does the addition of a homeopathy referral to usual care improve short term outcomes for patients with a diagnosis of Primary Fibromyalgia?

Ethics approval

Not provided at time of registration

Study design

Prospective pragmatic parallel group single blind randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Fibromyalgia

Intervention

Homeopathy referral + usual care vs usual care.

Intervention type

Drug

Phase

Not Specified

Drug names

Homeopathy

Primary outcome measures

Difference between the Fibromyalgia Impact Questionnaire (FIQ) total score (0-80 with 0 indicating no impact), at week 22, between the experimental and control groups.

Secondary outcome measures

1.Short form McGill Pain Questionnaire
2. Measure Your Medical Outcomes Profile (MYMOP)
3. FIQ Pain score
4. FIQ fatigue score
5. FIQ tiredness on awakening score
6. FIQ stiffness score
7. EQ-5D Quality of life score
8. Hospital anxiety and depression scale (HAD)
9. Tender point count (Performed by blinded assessor)
10. Medication Change Questionnaire

Overall trial start date

01/01/2006

Overall trial end date

07/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary Fibromyalgia diagnoses (According to American College of Rheumatologists criteria for FMS)
2. Aged 18 years old and over
3. Score of 4 or more on FIQ pain scale (score 0-10 with 10 indicating very severe pain) at initial recruitment/assessment interview

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

30 test participants, 30 controls

Participant exclusion criteria

1. Pain from traumatic injury or structural disease
2. Secondary Fibromyalgia
3. Rheumatoid Arthritis
4. Inflammatory Arthritis
5. Autoimmune Disease
6. Immunosuppressant Drugs
7. Current oral steroid treatment
8. Substance abuse in last year
9. Primary psychiatric diagnosis or medication prior to onset of Fibromyalgia
10. Unstable medical or psychiatric illness
11. Chronic use of sedatives
12. Pregnant or breast feeding
13. Current acupuncture treatment
14. Homeopathic treatment in the previous three months
15. Patients not fluent in English

Recruitment start date

01/01/2006

Recruitment end date

07/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Rheumatology
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barnsley Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BDGH Small Projects Fund

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19358959

Publication citations

  1. Results

    Relton C, Smith C, Raw J, Walters C, Adebajo AO, Thomas KJ, Young TA, Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial., Homeopathy, 2009, 98, 2, 77-82, doi: 10.1016/j.homp.2008.12.004.

Additional files

Editorial Notes