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

ISRCTN	ISRCTN01680675
DOI	https://doi.org/10.1186/ISRCTN01680675
Clinical Trials Information System (CTIS)	2005-002475-32
Protocol serial number	050526 FMS
Sponsor	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Funder	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Submission date: 16/10/2007
Registration date: 06/02/2008
Last edited: 19/05/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dr. Claudia Spies
Scientific

Charite - Universitatsmedizin Berlin
Chariteplatz 1
Berlin
D-10117
Germany

Phone	+49 (0)30 450 531 012/52
Email	claudia.spies@charite.de

Study information

Primary study design	Interventional
Study design	Placebo-controlled double-blind randomised pilot study
Secondary study design	Randomised controlled trial
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
Study acronym	FMS
Study objectives	Title in German: Pilotstudie zu den endokrinologischen, peripherphysiologischen und schmerzreduzierenden Effekten von Gamm-Hydroxybuttersäure in Kombination mit operant-verhaltenstherapeutischer Schmerztherapie bei Patienten mit Fibromyalgiesyndrom In our study we will test the following hypotheses: 1. After the multimodal therapy composed of gamma-hydroxybutyric acid (GHB) and behavioural therapy (operant pain therapy) in the experimental group in comparision with the control group, we expect a decrease of pain-induced damage, the rate of consultations in the last 12 months and the multidimensional pain inventory (MPI) (primary target goals) 2. The intake of GHB in the experimental group increases growth hormone and cortisol and decreases adrenocorticotropic hormone (ACTH). We expect an increase of muscular tension, a decrease of blood pressure, heart rate and resistance of the skin. A potential effect of GHB increases life control and reduces depressive mood (secondary target goals) On 03/07/2008 the sources of funding field was updated. The previous text was: 'German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - grant application pending' On 14/01/2009 the anticipated end date was changed from 01/12/2008 to 01/12/2009. On 04/02/2010 the anticipated end date was changed from 01/12/2009 to 31/12/2010.
Ethics approval(s)	Ethics board committee Berlin, Landesamt fur Gesundheit und Soziales (LaGeSo), 30/11/2005, ref: EA1/160/05
Health condition(s) or problem(s) studied	Fibromyalgia
Intervention	GHB oral
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gamma-hydroxybutyric acid (GHB)
Primary outcome measure(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
Key secondary outcome measure(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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany

Study participating centre

Charite - Universitatsmedizin Berlin

Berlin
D-10117
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		09/09/2020	19/05/2022	No	No

Editorial Notes

19/05/2022: EU Clinical Trials Register results added.