Condition category
Nervous System Diseases
Date applied
25/10/2007
Date assigned
27/03/2008
Last edited
08/09/2011
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

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Carbostesin

Primary outcome measures

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 trial start date

01/09/2007

Overall trial end date

31/12/2007

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.charite.de/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes