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

NCT ID: NCT00946738

Last Updated: 2009-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Raynaud's Phenomenon Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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physical therapy

Group Type ACTIVE_COMPARATOR

Biofeedback

Intervention Type OTHER

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

Deep oscillation

Intervention Type OTHER

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

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Biofeedback

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

Intervention Type OTHER

Deep oscillation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ACR criteria for SSc

Exclusion Criteria

* acute inflammatory disease, Valentini Score\>3
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Physiomed Elektromedizin AG Germany

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Department of Physical Medicine and Rehabilitation , Charité Berlin

Locations

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Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin

Berlin, 10117, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 21476099 (View on PubMed)

Other Identifiers

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EA 1/100/05

Identifier Type: -

Identifier Source: org_study_id

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