Raynaud's PhenomenonNCT00946738
The Effect of Physical Therapy on Raynaud's Phenomenon Secondary to Systemic Sclerosis
A study testing Biofeedback and Deep oscillation in people with Raynaud's Phenomenon and Systemic Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Raynaud's Phenomenon, Systemic Sclerosis
- What is being tested?
- Biofeedback and Deep oscillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACR criteria for SSc
Who cannot join
- acute inflammatory disease, Valentini Score>3
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Physical Medicine and Rehabilitation , Charité University Hospital Berlin
Berlin, 10117
About this study
Official title: A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation 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.
- Conditions
- Raynaud's Phenomenon, Systemic Sclerosis
- Being tested
- Biofeedback, Deep oscillation
- Keywords
- Raynaud's phenomenon, biofeedback, deep oscillation, systemic sclerosis, physiotherapy
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackOther
Biofeedback training as behaviour treatment was performed thrice weekly for 4 week.
Deep oscillationOther
Deep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy | Active comparator | Not described Receives: Other: Biofeedback; Other: Deep oscillation |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP score , measured by a visual analogue scale (VAS)
Measured: 12 weeks
Secondary outcomes (1)
ulceration of the skin and general disease symptoms using analogous VAS-scores
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startOct 2004
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud's PhenomenonStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Physiomed Elektromedizin AG Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946738
- Sponsor's protocol ID
- EA 1/100/05
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21476099
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Analyzing the Effect of Biofeedback and Deep Oscillation on Raynaud´s Phenomenon Secondary to Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00946738
- Acronym / sponsor ID
- EA 1/100/05
- Conditions
- Raynaud's Phenomenon, Systemic Sclerosis
- Keywords
- Raynaud's phenomenon, biofeedback, deep oscillation, systemic sclerosis, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Physiomed Elektromedizin AG Germany
- Study start
- Oct 2004
- Primary completion
- Mar 2008 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy | Active comparator | Other: Biofeedback, Other: Deep oscillation |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACR criteria for SSc
Key exclusion criteria (1 listed)
- acute inflammatory disease, Valentini Score>3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackBiofeedback training as behaviour treatment was performed thrice weekly for 4 week. | Other | physical therapy |
| Deep oscillationDeep oscillation providing a pulsing electromagnetic field was performed thrice weekly for 4 weeks. | Other | physical therapy |
Primary outcome
RP score , measured by a visual analogue scale (VAS)
Time frame: 12 weeks
1 secondary outcome
ulceration of the skin and general disease symptoms using analogous VAS-scores
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
- Derived from this study: PubMed 21476099Sporbeck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback and Deep oscillation in people with Raynaud's Phenomenon and Systemic Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP score , measured by a visual analogue scale (VAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2009.