Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome

ISRCTN	ISRCTN74040048
DOI	https://doi.org/10.1186/ISRCTN74040048
Secondary identifying numbers	N0034178702

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Ade Adebajo
Scientific

Dept of Rheumatology
Barnsley District General Hospital
Gawber Road
Barnsley
S75 2EP
United Kingdom

Phone	+44 01226 777867
Email	a.o.adebajo@sheffield.ac.uk

Study design	Prospective pragmatic parallel group single blind randomised controlled pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
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(s)	Not provided at time of registration
Condition	Musculoskeletal Diseases: Fibromyalgia
Intervention	Homeopathy referral + usual care vs usual care.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Homeopathy
Primary outcome measure	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 study start date	01/01/2006
Overall study end date	07/07/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	30 test participants, 30 controls
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 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

Dept of Rheumatology

Barnsley
S75 2EP
United Kingdom

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barnsley Hospital NHS Foundation Trust

No information available

BDGH Small Projects Fund

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009		Yes	No