Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Gustav Schelling,MD, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00236925
First received: October 10, 2005
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Drug: Low dose Hydrocortisone
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Fibromyalgia symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chronic stress symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Life satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2003
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose Hydrocortisone
Low Dose Hydrocortisone
Drug: Low dose Hydrocortisone
Hydrocortisone 10 mg daily
Other Name: Cortisol
Drug: Placebo
Placebo
Other Name: Placebo
Placebo Comparator: Placebo
Placebo

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236925

Locations
Germany
Ludwig-Maximilians University
Muenchen, Bavaria, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
University of Zurich
Investigators
Principal Investigator: Gustav Schelling, MD, PhD Ludwig-Maximilians - University of Munich
  More Information

Additional Information:
Publications:
Responsible Party: Gustav Schelling,MD, Senior Researcher, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00236925     History of Changes
Other Study ID Numbers: 348/02
Study First Received: October 10, 2005
Last Updated: March 30, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Fibromyalgia
Cortisol
Hydrocortisone
Stress

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015