Contact information
Type
Scientific
Contact name
Prof Dr. Claudia Spies
ORCID ID
Contact details
Charite - Universitatsmedizin Berlin
Chariteplatz 1
Berlin
D-10117
Germany
+49 (0)30 450 531 012/52
claudia.spies@charite.de
Additional identifiers
EudraCT/CTIS number
2005-002475-32
IRAS number
ClinicalTrials.gov number
Protocol/serial number
050526 FMS
Study information
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
Acronym
FMS
Study hypothesis
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
Study design
Placebo-controlled double-blind randomised pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Fibromyalgia
Intervention
GHB oral
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Gamma-hydroxybutyric acid (GHB)
Primary outcome measure
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 measures
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
Overall study start date
01/10/2006
Overall study end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
40
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany
Study participating centre
Charite - Universitatsmedizin Berlin
Berlin
D-10117
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
c/o Professor Claudia Spies
Kliniken für Anästhesiologie und operative Intensivmedizin CVK und CCM
Schmerzambulanz Campus Charite Mitte
Charitè Universitätsmedizin Berlin
Chariteplatz 1
Berlin
D-10117
Germany
-
claudia.spies@charite.de
Sponsor type
Other
Website
ROR
Funders
Funder type
Government
Funder name
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
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 |