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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN39729827 |
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Date of registration:
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27/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigation of the effectiveness of BioFeedBack therapy on Complex Regional Pain Syndrome (CRPS) of the upper extremity
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Scientific title:
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Date of first enrolment:
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01/09/2007 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN39729827 |
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Study type:
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Interventional |
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Study design:
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Prospective randomised controlled single centre interventional study (Treatment)
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Anja
Heymann |
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Address:
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Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care
Augustenburger Platz 1
13353
Berlin
Germany |
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Telephone:
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+49 (0)304 5055 1012 |
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Email:
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anja.heymann@charite.de |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complex regional pain syndrome
Nervous System Diseases
Causalgia
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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