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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN74040048 |
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Date of registration:
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28/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome
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Scientific title:
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Date of first enrolment:
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01/01/2006 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN74040048 |
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Study type:
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Interventional |
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Study design:
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Prospective pragmatic parallel group single blind randomised controlled pilot study (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ade
Adebajo |
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Address:
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Dept of Rheumatology
Barnsley District General Hospital
Gawber Road
S75 2EP
Barnsley
United Kingdom |
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Telephone:
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+44 01226 777867 |
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Email:
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a.o.adebajo@sheffield.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Musculoskeletal Diseases: Fibromyalgia
Musculoskeletal Diseases
Fibromyalgia
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Intervention(s)
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Homeopathy referral + usual care vs usual care.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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N0034178702
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Source(s) of Monetary Support
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Barnsley Hospital NHS Foundation Trust, BDGH Small Projects Fund
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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