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Can patients with fibromyalgia be improved by subcutaneous injections of sterile water in tenderpoints? A randomised, controlled, tripple masked clinical trial

Conditions
Fibromyalgia
Registration Number
EUCTR2005-000654-67-SE
Lead Sponsor
ppsala University/Uppsala County Council
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Female
Target Recruitment
60
Inclusion Criteria

Women, less than 65 years old, non-pregnant, non-brest feeding
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Symptoms or signs of rheumatoid arthritis, multiple sclerosis, malignancy, or other serious disease

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To test the hypothesis that injections of sterile water in the tenderpoints relieves the pain symptoms during at least one year;Secondary Objective: The pain relief is caused by a resetting of the nosoceptors, in turn caused by changes in the release of neuropeptides;Primary end point(s): Number of tenderpoints, arm abduction test, chair raising test, and a set of quality of life measures
Secondary Outcome Measures
NameTimeMethod
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