Back to resultsThe Effect of Physical Therapy on Raynaud's Phenomenon Secondary to Systemic Sclerosis
Primary Purpose
Raynaud's Phenomenon, Systemic Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Biofeedback
Deep oscillation
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud's Phenomenon focused on measuring Raynaud's phenomenon, biofeedback, deep oscillation, systemic sclerosis, physiotherapy
Eligibility Criteria
Inclusion Criteria:
- ACR criteria for SSc
Exclusion Criteria:
- acute inflammatory disease, Valentini Score>3
Sites / Locations
- Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
physical therapy
control
Arm Description
Outcomes
Primary Outcome Measures
RP score , measured by a visual analogue scale (VAS)
Secondary Outcome Measures
ulceration of the skin and general disease symptoms using analogous VAS-scores
Full Information
NCT ID
NCT00946738
First Posted
July 24, 2009
Last Updated
July 24, 2009
Sponsor
Charite University, Berlin, Germany
Collaborators
Physiomed Elektromedizin AG Germany
1. Study Identification
Unique Protocol Identification Number
NCT00946738
Brief Title
The Effect of Physical Therapy on Raynaud's Phenomenon Secondary to Systemic Sclerosis
Official Title
A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation on Raynaud´s Phenomenon Secondary to Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Physiomed Elektromedizin AG Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Phenomenon, Systemic Sclerosis
Keywords
Raynaud's phenomenon, biofeedback, deep oscillation, systemic sclerosis, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Arm Title
physical therapy
Arm Type
Active Comparator
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Biofeedback
Intervention Description
Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.
Intervention Type
Other
Intervention Name(s)
Deep oscillation
Intervention Description
Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.
Primary Outcome Measure Information:
Title
RP score , measured by a visual analogue scale (VAS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ulceration of the skin and general disease symptoms using analogous VAS-scores
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ACR criteria for SSc
Exclusion Criteria:
acute inflammatory disease, Valentini Score>3
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin
City
Berlin
State/Province
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21476099
Citation
Sporbeck B, Mathiske-Schmidt K, Jahr S, Huscher D, Becker M, Riemekasten G, Taufmann I, Burmester GR, Pogel 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. doi: 10.1007/s00296-011-1882-2. Epub 2011 Apr 8.
Results Reference
derived
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The Effect of Physical Therapy on Raynaud's Phenomenon Secondary to Systemic Sclerosis
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