Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome

ISRCTN	ISRCTN74040048
DOI	https://doi.org/10.1186/ISRCTN74040048
Protocol serial number	N0034178702
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Barnsley Hospital NHS Foundation Trust, BDGH Small Projects Fund

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Primary study design	Interventional
Study design	Prospective pragmatic parallel group single blind randomised controlled pilot study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	Musculoskeletal Diseases: Fibromyalgia
Intervention	Homeopathy referral + usual care vs usual care.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Homeopathy
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	07/07/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	07/07/2007

Dept of Rheumatology

Barnsley
S75 2EP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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