NCT00946738

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

July 27, 2009

Status Verified

July 1, 2009

Enrollment Period

3.4 years

First QC Date

July 24, 2009

Last Update Submit

July 24, 2009

Conditions

Raynaud's PhenomenonSystemic Sclerosis

Keywords

Raynaud's phenomenonbiofeedbackdeep oscillationsystemic sclerosisphysiotherapy

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (2)

physical therapy

ACTIVE COMPARATOR
Other: BiofeedbackOther: Deep oscillation

control

NO INTERVENTION

Interventions

BiofeedbackOTHER

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

physical therapy
Deep oscillationOTHER

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

physical therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACR criteria for SSc

You may not qualify if:

  • acute inflammatory disease, Valentini Score\>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21476099DERIVED

MeSH Terms

Conditions

Raynaud DiseaseScleroderma, Systemic

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesConnective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

October 1, 2004

Primary Completion

March 1, 2008

Last Updated

July 27, 2009

Record last verified: 2009-07

Locations

DE(1)