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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946738
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : July 27, 2009
Physiomed Elektromedizin AG Germany
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Systemic Sclerosis Other: Biofeedback Other: Deep oscillation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation on Raynaud´s Phenomenon Secondary to Systemic Sclerosis
Study Start Date : October 2004
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Active Comparator: physical therapy 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.

No Intervention: control

Primary Outcome Measures :
  1. RP score , measured by a visual analogue scale (VAS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. ulceration of the skin and general disease symptoms using analogous VAS-scores [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ACR criteria for SSc

Exclusion Criteria:

  • acute inflammatory disease, Valentini Score>3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946738

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Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin
Berlin, 10117, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Physiomed Elektromedizin AG Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anett Reißhauer MD, Department of Physical Medicine and Rehabilitation , Charité Berlin Identifier: NCT00946738    
Other Study ID Numbers: EA 1/100/05
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: July 27, 2009
Last Verified: July 2009
Keywords provided by Charite University, Berlin, Germany:
Raynaud's phenomenon
deep oscillation
systemic sclerosis
Additional relevant MeSH terms:
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Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases