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Register:	ISRCTN
Last refreshed on:	30 May 2022
Main ID:	ISRCTN01680675
Date of registration:	06/02/2008
Prospective Registration:	No
Primary sponsor:	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Public title:	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
Scientific title:	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
Date of first enrolment:	01/10/2006
Target sample size:	40
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN01680675
Study type:	Interventional
Study design:	Placebo-controlled double-blind randomised pilot study (Treatment)
Phase:	Not Specified

Countries of recruitment
Germany

Contacts

Name:	Dr. Claudia Spies
Address:	Charite - Universitatsmedizin Berlin Chariteplatz 1 D-10117 Berlin Germany
Telephone:	+49 (0)30 450 531 012/52
Email:	claudia.spies@charite.de
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Fibromyalgia
Musculoskeletal Diseases
Fibromyalgia

Intervention(s)

GHB oral

Primary Outcome(s)

1. Number of physician consultations in the last 12 months
2. Multidimensional Pain Inventory (MPI)

Outcomes measured at:
1. Pre-examination: start of the intake of study drug
2. Two months after starting the intake of study drug
3. Post-examination: end of the intake of study drug
4. Catamnesis 1: 2 months after the intake of study drug
5. Catamnesis 2: 6 months after the intake of PP

Secondary Outcome(s)

1. Muscular tension
2. Blood pressure
3. Heart rate
4. Resistance of the skin
5. Assessment of life control and depressive mood

Outcomes measured at:
1. Pre-examination: start of the intake of study drug
2. Two months after starting the intake of study drug
3. Post-examination: end of the intake of study drug
4. Catamnesis 1: 2 months after the intake of study drug
5. Catamnesis 2: 6 months after the intake of PP

Secondary ID(s)

2005-002475-32

050526 FMS

Source(s) of Monetary Support

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics board committee Berlin, Landesamt fur Gesundheit und Soziales (LaGeSo), 30/11/2005, ref: EA1/160/05

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2010
URL:

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