|
ISRCTN
|
ISRCTN39729827
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Investigation of the effectiveness of BioFeedBack therapy on Complex Regional Pain Syndrome (CRPS) of the upper extremity
|
|
Scientific title
|
|
|
Acronym
|
CRPS-BFB
|
|
Serial number at source
|
N/A
|
|
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
|
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
|
|
Countries of recruitment
|
Germany
|
|
Disease/condition/study domain
|
Complex regional pain syndrome
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/09/2007
|
|
Anticipated end date
|
31/12/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
30
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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.
|
|
Sources of funding
|
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Anja
Heymann
|
|
Address
|
Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care
Augustenburger Platz 1
|
|
City/town
|
Berlin
|
|
Zip/Postcode
|
13353
|
|
Country
|
Germany
|
|
Tel
|
+49 (0)304 5055 1012
|
|
Fax
|
+49 (0)304 5055 1119
|
|
Email
|
anja.heymann@charite.de
|
|
Sponsor
|
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
|
|
Address
|
c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
|
|
City/town
|
Berlin
|
|
Zip/Postcode
|
D-13353
|
|
Country
|
Germany
|
|
Tel
|
+49 (0)304 5055 1002
|
|
Fax
|
+49 (0)304 5055 1119
|
|
Email
|
claudia.spies@charite.de
|
|
Sponsor website:
|
http://www.charite.de/
|
|
Date applied
|
25/10/2007
|
|
Last edited
|
27/03/2008
|
|
Date ISRCTN assigned
|
27/03/2008
|
