|
Welcome
|
|
21 November 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN74040048 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0034178702 |
| Public title | Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Fibromyalgia |
| Study hypothesis | Does the addition of a homeopathy referral to usual care improve short term outcomes for patients with a diagnosis of Primary Fibromyalgia? |
| Design/methodology | Prospective pragmatic parallel group single blind randomised controlled pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/01/2006 |
| Anticipated end date | 07/07/2007 |
| Status of trial | Completed |
| Target number of participants | 30 test participants, 30 controls |
| Interventions | Homeopathy referral + usual care vs usual care. |
| 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. |
| 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 |
| Sources of funding | Barnsley Hospital NHS Foundation Trust BDGH Small Projects Fund |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall London United Kingdom SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Ade Adebajo |
| Contact details | Dept of Rheumatology Barnsley District General Hospital Gawber Road Barnsley United Kingdom S75 2EP |
| Contact telephone | +44 01226 777867 |
| Contact fax | +44 01226 202859 |
| Contact email | adewale.adebajo@bhnft.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN74040048 |
| Date last extracted from ISRCTN register | 17/04/2008 |
|
|
|
| terms & conditions | privacy statement | © Current Controlled Trials Ltd | |
|
|
|
|