Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00236925|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Low dose Hydrocortisone Drug: Placebo||Early Phase 1|
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
2 x 5 mg of hydrocortisone given at noon and in the evening
Double-blind, randomized, cross-over, within-subject
Presumed mechanism of main hydrocortisone effect:
- Improvements in FMS symptoms representing (functional) hypocortisolism
- Increased pain threshold
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||June 2007|
Active Comparator: Low dose Hydrocortisone
Low Dose Hydrocortisone
Drug: Low dose Hydrocortisone
Hydrocortisone 10 mg daily
Other Name: CortisolDrug: Placebo
Placebo Comparator: Placebo
- Fibromyalgia symptoms [ Time Frame: 3 months ]
- Chronic stress symptoms [ Time Frame: 3 months ]
- Health-related quality of life [ Time Frame: 3 months ]
- Life satisfaction [ Time Frame: 3 months ]
- Infection [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236925
|Muenchen, Bavaria, Germany, 81377|
|Principal Investigator:||Gustav Schelling, MD, PhD||Ludwig-Maximilians - University of Munich|