The Effect of Physical Therapy on Raynaud`s Phenomenon Secondary to Systemic Sclerosis

This study has been completed.

Sponsor:

Collaborator:

Physiomed Elektromedizin AG Germany

Information provided by:

Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT00946738

First received: July 24, 2009

Last updated: NA

Last verified: July 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 24, 2009
Last Updated Date	July 24, 2009
Start Date ^ICMJE	October 2004
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2009)	RP score , measured by a visual analogue scale (VAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 24, 2009)	ulceration of the skin and general disease symptoms using analogous VAS-scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Physical Therapy on Raynaud`s Phenomenon Secondary to Systemic Sclerosis
Official Title ^ICMJE	A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation on Raynaud´s Phenomenon Secondary to Systemic Sclerosis
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Condition ^ICMJE	Raynaud's Phenomenon Systemic Sclerosis
Intervention ^ICMJE	Other: Biofeedback Biofeedback training as behaviour treatment was performed thrice weekly for 4 week. Other: Deep oscillation Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.
Study Arm (s)	Active Comparator: physical therapy Interventions: Other: Biofeedback Other: Deep oscillation No Intervention: control
Publications *	Sporbeck B, Mathiske-Schmidt K, Jahr S, Huscher D, Becker M, Riemekasten G, Taufmann I, Burmester GR, Pögel S, Reisshauer A. Effect of biofeedback and deep oscillation on Raynaud's phenomenon secondary to systemic sclerosis: results of a controlled prospective randomized clinical trial. Rheumatol Int. 2012 May;32(5):1469-73. Epub 2011 Apr 8.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date	Not Provided
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ACR criteria for SSc Exclusion Criteria: acute inflammatory disease, Valentini Score>3
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00946738
Other Study ID Numbers ^ICMJE	EA 1/100/05
Has Data Monitoring Committee	Yes
Responsible Party	Anett Reißhauer MD, Department of Physical Medicine and Rehabilitation , Charité Berlin
Study Sponsor ^ICMJE	Charite University, Berlin, Germany
Collaborators ^ICMJE	Physiomed Elektromedizin AG Germany
Investigators ^ICMJE	Not Provided
Information Provided By	Charite University, Berlin, Germany
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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