Investigation of the effectiveness of BioFeedBack therapy on Complex Regional Pain Syndrome (CRPS) of the upper extremity
| ISRCTN | ISRCTN39729827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39729827 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/10/2007
- Registration date
- 27/03/2008
- Last edited
- 08/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Anja Heymann
Scientific
Scientific
Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care
Augustenburger Platz 1
Berlin
13353
Germany
| Phone | +49 (0)304 5055 1012 |
|---|---|
| anja.heymann@charite.de |
Study information
| 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 |
| Scientific title | |
| Study 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). |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| 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 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
13353
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
University/education
University/education
c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
D-13353
Germany
| Phone | +49 (0)304 5055 1002 |
|---|---|
| claudia.spies@charite.de | |
| Website | http://www.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
