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
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ulceration of the skin and general disease symptoms using analogous VAS-scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACR criteria for SSc

Exclusion Criteria:

  • acute inflammatory disease, Valentini Score>3
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00946738

Locations
Germany
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

No publications provided by Charite University, Berlin, Germany

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

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

Additional relevant MeSH terms:
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014