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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946738
• Other study ID #: EA 1/100/05
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: July 24, 2009
• Start date: October 2004

Study information

• Verified date: July 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ACR criteria for SSc

Exclusion Criteria:

• acute inflammatory disease, Valentini Score>3

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Phenomenon
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Biofeedback
Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.
• Deep oscillation
Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.

Locations

Country	Name	City	State
Germany	Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin	Berlin	10117

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Physiomed Elektromedizin AG Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RP score , measured by a visual analogue scale (VAS)		12 weeks	No
Secondary	ulceration of the skin and general disease symptoms using analogous VAS-scores		12 weeks	No