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

This study has been completed.
Physiomed Elektromedizin AG Germany
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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 Intervention
Raynaud's Phenomenon Systemic Sclerosis Other: Biofeedback Other: Deep oscillation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

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

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

Estimated Enrollment: 28
Study Start Date: October 2004
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Inclusion Criteria:

  • ACR criteria for SSc

Exclusion Criteria:

  • acute inflammatory disease, Valentini Score>3
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Please refer to this study by its identifier: NCT00946738

Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin
Berlin, 10117, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Physiomed Elektromedizin AG Germany
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anett Reißhauer MD, Department of Physical Medicine and Rehabilitation , Charité Berlin Identifier: NCT00946738     History of Changes
Other Study ID Numbers: EA 1/100/05
Study First Received: July 24, 2009
Last Updated: July 24, 2009

Keywords provided by Charite University, Berlin, Germany:
Raynaud's phenomenon
deep oscillation
systemic sclerosis

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 19, 2017