Condition category
Musculoskeletal Diseases
Date applied
16/10/2007
Date assigned
06/02/2008
Last edited
02/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

2005-002475-32

ClinicalTrials.gov number

Protocol/serial number

050526 FMS

Study information

Scientific title

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

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Fibromyalgia

Intervention

GHB oral

Intervention type

Drug

Phase

Not Specified

Drug names

Gamma-hydroxybutyric acid (GHB)

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

31/12/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.charite.de/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes