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OpenTrials
Completed

NCT Number: NCT00946738

The Effect of Physical Therapy 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.

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Key information

Conditions

Raynaud's Phenomenon Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Sclerosis Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ACR criteria for SSc

Exclusion criteria

  • acute inflammatory disease, Valentini Score>3

Treatment and study plan

Biofeedback

Other

Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.

Deep oscillation

Other

Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.

Primary outcomes

  1. RP score , measured by a visual analogue scale (VAS)

    Time frame: 12 weeks

Secondary outcomes

  1. ulceration of the skin and general disease symptoms using analogous VAS-scores

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Physiomed Elektromedizin AG Germany

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
First posted
Jul 27, 2009
Registry last updated
Jul 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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