Primary Raynaud's PhenomeonNCT01784354
Acupressure for the Treatment of Raynaud's Phenomenon
A study testing Acupressure, Acupressure dilatation and education in people with Primary Raynaud's Phenomeon, run by University of Michigan at 1 site in United States.
Trial summary
The use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Raynaud's Phenomeon
- What is being tested?
- Acupressure, Acupressure dilatation and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- Have Raynauds phenomenon, with at least 4 attacks in the last week
- on stable medications
- Willing to attend study visits
Who cannot join
- smoker
- have a history of stroke, heart attack or irregular heart rhythm
- uncontrolled blood pressure
- physical or mental illness that would interfere with participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupressure in Raynaud's Phenomenon- A Pilot Study.
The use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks.
Read the detailed description
Using a Raynaud's condition score, severity of tingling, numbness and pain of attacks, the number of attacks and patient and physician visual analog scale we will assess the effect of acupressure.
- Conditions
- Primary Raynaud's Phenomeon
- Being tested
- Acupressure, Acupressure dilatation, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure dilatationOther
educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Education | Placebo comparator | target education toward Raynaud's Receives: Behavioral: education |
| Acupressure | Active comparator | acupressure- dilatation Receives: Other: Acupressure dilatation |
| Acupressure relaxation | Active comparator | acupressure relaxation protocol Receives: Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in number of Raynaud's attacks
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Raynaud's PhenomeonStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Gladue, DO, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784354
- Sponsor's protocol ID
- HUM00062868
- Status last verified
- Jun 2013
- First submitted
- 18 Jan 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure in Raynaud's Phenomenon- A Pilot Study.
- ClinicalTrials.gov ID
- NCT01784354
- Acronym / sponsor ID
- HUM00062868
- Conditions
- Primary Raynaud's Phenomeon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Feb 2013 (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 use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks.
Detailed description
Using a Raynaud's condition score, severity of tingling, numbness and pain of attacks, the number of attacks and patient and physician visual analog scale we will assess the effect of acupressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education | Placebo comparator | Behavioral: educationtarget education toward Raynaud's |
| Acupressure | Active comparator | Other: Acupressure dilatationacupressure- dilatation |
| Acupressure relaxation | Active comparator | Other: Acupressureacupressure relaxation protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old
- Have Raynauds phenomenon, with at least 4 attacks in the last week
- on stable medications
- Willing to attend study visits
Key exclusion criteria (4 listed)
- smoker
- have a history of stroke, heart attack or irregular heart rhythm
- uncontrolled blood pressure
- physical or mental illness that would interfere with participating in the study
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 |
|---|---|---|
| Acupressure | Other | Acupressure relaxation |
| Acupressure dilatation | Other | Acupressure |
| education | Behavioural | Education |
Primary outcome
Decrease in number of Raynaud's attacks
Time frame: 1-2 years
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 12 Jun 2013.
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 Acupressure, Acupressure dilatation and education in people with Primary Raynaud's Phenomeon, run by University of Michigan at 1 site in United States.
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 4 inclusion and 4 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 12 Jun 2013. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Decrease in number of Raynaud's attacks (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2013.