Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00236925 |
Other study ID # |
348/02 |
Secondary ID |
|
Status |
Completed |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
May 2003 |
Est. completion date |
June 2007 |
Study information
Verified date |
March 2024 |
Source |
Ludwig-Maximilians - University of Munich |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is based on clinical findings that some patients with fibromyalgia have a tendency
towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this
study is that the administration of a very low-dose of cortisol which has no side effects
corrects this deficiency and results in an improvement of symptoms
Description:
Fibromyalgia (FMS) is regarded as one of the most important chronic pain syndromes with a
high prevalence in the general population.
Hypotheses to be tested in this study:
- Impaired glucocorticoid signaling is associated in a failure to terminate the chronic
stress response seen in patients with FMS.
- Low-dose hydrocortisone in patients with FMS results in a reduction in pain and other
stress-related symptoms of FMS
Intervention:
2 x 5 mg of hydrocortisone given at noon and in the evening
Study design:
Double-blind, randomized, cross-over, within-subject
Presumed mechanism of main hydrocortisone effect:
- Improvements in FMS symptoms representing (functional) hypocortisolism
- Increased pain threshold
Expected results:
- Moderate reductions in physical impairment, fatigue, and stiffness
- Improvements in sleep quality
- Decline in pain intensity Inclusion criteria
- FMS diagnosis according to the American College of Rheumatology 1990 Criteria
- Age between 18 and 60 years
Exclusion criteria
- Disease states representing contraindications to the administration of glucocorticoids
(tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis,
hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus,
thrombophilia, active or chronic bacterial or viral infections, hypothyreosis,
cirrhosis).
- Severe or chronic somatic diseases.
- Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor
personality disorders).
- Body weight >20% above or below normal.
- Changes in pharmacologic or psychotherapeutic management less than 3 months ago.
- Age < 18 years
Proposed outcome measures
- Primary: FMS symptoms, pain scores, tenderness at tender points
- Secondary: Chronic stress symptoms, health-related quality of life
Possible benefit and use of data from the trial
This trial could help to identify glucocorticoid resistance as a major mechanism underlying
the sustained stress - reactions seen in FMS and establish low-dose hydrocortisone as a
useful drug for treatment of stress-related disorders.