Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236925
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2005-10-10
Brief Title:
Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Cushings 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
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 Cushings 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None