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

July 24, 2009 updated by: Charite University, Berlin, Germany

A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation on Raynaud´s Phenomenon Secondary to Systemic Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • 10117
      • Berlin, 10117, Germany
        • Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ACR criteria for SSc

Exclusion Criteria:

  • acute inflammatory disease, Valentini Score>3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RP score , measured by a visual analogue scale (VAS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ulceration of the skin and general disease symptoms using analogous VAS-scores
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Physiomed Elektromedizin AG Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA 1/100/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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