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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00946738
Other study ID # EA 1/100/05
Secondary ID
Status Completed
Phase N/A
First received July 24, 2009
Last updated July 24, 2009
Start date October 2004

Study information

Verified date July 2009
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The effect of deep oscillation and biofeedback on Raynaud`s phenomenon secondary to systemic sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for four weeks or were randomized to the control group.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- ACR criteria for SSc

Exclusion Criteria:

- acute inflammatory disease, Valentini Score>3

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Other:
Biofeedback
Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.
Deep oscillation
Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.

Locations

Country Name City State
Germany Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin Berlin 10117

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany Physiomed Elektromedizin AG Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary RP score , measured by a visual analogue scale (VAS) 12 weeks No
Secondary ulceration of the skin and general disease symptoms using analogous VAS-scores 12 weeks No
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