Pilot study to investigate the endocrinological, physiological and pain-reducing effects of gamma-hydroxybutyric acid in combination with operant behaviour pain therapy on patients with FibroMyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia; Musculoskeletal Diseases

• Registration Number: ISRCTN01680675
• Lead Sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-06
• Study Completion: 2010-12-31
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Verified fibromyalgia
2. Female sex
3. Sound command of German language
4. Motivation for therapy
5. Minimum age 18 years
6. Written informed consent

Exclusion Criteria

1. Patients under 18 years or older than 80 years
2. Pregnancy
3. Psychiatric desease
4. Treatment with opioids
5. Treatment with sedative drugs
6. Current intake of anti-depressants
7. Pension demand
8. Patients without the possibility to give their consent
9. Arterial hypertension
10. Epilepsy
11. Severe renal failure
12. Intoxication with alcohol
13. Inclusion in another study within the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Number of physician consultations in the last 12 months<br> 2. Multidimensional Pain Inventory (MPI)<br><br> Outcomes measured at:<br> 1. Pre-examination: start of the intake of study drug<br> 2. Two months after starting the intake of study drug<br> 3. Post-examination: end of the intake of study drug<br> 4. Catamnesis 1: 2 months after the intake of study drug<br> 5. Catamnesis 2: 6 months after the intake of PP<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Muscular tension<br> 2. Blood pressure<br> 3. Heart rate<br> 4. Resistance of the skin<br> 5. Assessment of life control and depressive mood<br><br> Outcomes measured at:<br> 1. Pre-examination: start of the intake of study drug<br> 2. Two months after starting the intake of study drug<br> 3. Post-examination: end of the intake of study drug<br> 4. Catamnesis 1: 2 months after the intake of study drug<br> 5. Catamnesis 2: 6 months after the intake of PP<br>