The Effect of Physical Therapy on Raynaud's Phenomenon Se... | NCT00946738

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

NCT00946738

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 27, 2009Estimated

Enrollment

Phase

Not Applicable

Conditions

Raynaud's Phenomenon
Systemic Sclerosis

Interventions

Biofeedback
Deep oscillation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Mar 2008Actual

Completion Date

Not provided

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2009

Last Update Posted Date

Jul 27, 2009Estimated

Name	Class
Physiomed Elektromedizin AG Germany	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
physical therapy	Active Comparator		Other: Biofeedback Other: Deep oscillation
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biofeedback	Other	Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.	physical therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ACR criteria for SSc

Exclusion Criteria:

acute inflammatory disease, Valentini Score>3

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin		Berlin	10117		Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21476099	Derived	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.

ID	Term
D011928	Raynaud Disease
D012595	Scleroderma, Systemic

ID	Term
D000090122	Livedoid Vasculopathy
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D001521	Behavior Therapy