Contact information
Type
Scientific
Contact name
Dr Anja Heymann
ORCID ID
Contact details
Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care
Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)304 5055 1012
anja.heymann@charite.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CRPS-BFB
Study hypothesis
Biofeedback therapy additional to the standard therapy (blockades of the stellate ganglion) enhances the pain reduction and the functionality of the complex regional pain syndrome (CRPS)-affected extremity compared to standard therapy alone.
Ethics approval(s)
Ethics approval received from the Ethikkommission der Charite-Universitatsmedizin Berlin on the 20th March 2006 (ref: EA 2/022/06).
Study design
Prospective randomised controlled single centre interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Complex regional pain syndrome
Intervention
In the active group, the patients get 10 sympathetic blockades of the stellate ganglion. The injections are performed twice a week during five weeks in a standardised manner: all patients get a blockade of the stellate ganglion of the affected side with 10 cc carbostesin 0.25%. The injections are performed twice a week. In addition, these patients are treated by 10 standardised biofeedback sessions (50 minutes) twice a week over five weeks. Biofeedback treatment and blockades are always performed at the same day.
In the control group, the patients get blockades of the stellate ganglion of the affected side in the same manner as in the active group. There is no additional therapy provided.
In both groups, pain, pain coping strategies and sensibility of nerve fibres are measured before starting the treatment and one week after the last treatment. A follow-up is provided six months after the last treatment.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Carbostesin
Primary outcome measure
Analgesia using the Visual Analogue Scale (VAS: 0 = no pain, 10 = unbearable pain).
The primary and secondary outcomes will be measured seven days after the end of the therapy and once again after six months.
Secondary outcome measures
1. Active pain coping strategies using the Questionnaire for Assessment of Level of Coping with Pain (Fragebogen zur Erfassung der Schmerzverarbeitung [FESV])
2. Sensibility of non- or little-myelinated nerve fibres using quantitative sensory testing (QST)
3. Functionality of the affected extremity using the wrist function scale, goniometric and dynamometric measures
The primary and secondary outcomes will be measured seven days after the end of the therapy and once again after six months.
Overall study start date
01/09/2007
Overall study end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. CRPS I or II of an upper extremity
2. Aged greater than 18 years
3. Stable pain medication during the last two weeks
4. Stable psychoactive medication during the last two months
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
30
Participant exclusion criteria
1. Current psychotherapy or psychiatric therapy
2. Major depression
3. Severe cognitive dysfunction or mental disorder
4. Suicidal tendencies
5. Psychosis
6. Participation in other studies in the same time
7. Use of benzodiazepines
8. Drug abuse
9. Contraindications against blockade of the stellate ganglion
Recruitment start date
01/09/2007
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Germany
Study participating centre
Charite - Universitatsmedizin Berlin
Berlin
13353
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
D-13353
Germany
+49 (0)304 5055 1002
claudia.spies@charite.de
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
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
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|