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
Protocol serial number	N/A
Sponsor	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Funder	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

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 of protocol

Not provided at time of registration

Contact information

Dr Anja Heymann
Scientific

Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care
Augustenburger Platz 1
Berlin
13353
Germany

Phone	+49 (0)304 5055 1012
Email	anja.heymann@charite.de

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled single centre interventional study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CRPS-BFB
Study objectives	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).
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Carbostesin
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.
Key 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.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Germany

Study participating centre

Charite - Universitatsmedizin Berlin

Berlin
13353
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan