Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
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
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2009 | Yes | No |