Angina PectorisSOMMANCT00708279
Study of Osteopathic Manipulation in the Management of Angina
A study testing Osteopathic manipulation in people with Angina Pectoris, run by University of New England at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Osteopathic manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 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 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Canadian Cardiovascular Society Class II, III for a minimum of 6 months
- documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel.
Who cannot join
- severe left ventricular dysfunction
- symptomatic heart failure
- symptomatic aortic stenosis or any valvular disease
- significant pulmonary disease
- unstable angina
- major surgery or angioplasty in the past three months
Show all 11Show fewer
- acute myocardial infarction within past three months
- insulin dependent diabetes mellitus
- uncontrolled hypertension
- acute renal or hepatic failure
- currently being treated with osteopathic manipulation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.
- Conditions
- Angina Pectoris
- Being tested
- Osteopathic manipulation
- Keywords
- angina pectoris, osteopathic manipulation
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulationProcedure or surgery
Also called osteopathic manipulative medicine, structural exam, viscero-somatic reflexes, circulatory-respirtatory model
Participant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | After establishing a baseline for the first 4 weeks of trial involvement, thereby providing their own control group, all participants begin the intervention phase of osteopathic manipulation. Receives: Procedure: Osteopathic manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in angina symptoms
Measured: over 4 month period
Secondary outcomes (1)
Improvement in quality of life
Measured: over 4 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopathic Heritage Foundations
- Investigators
- Joy L. Palmer, D.O., Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708279
- Sponsor's protocol ID
- F-07-04 SOMMA
- Other IDs
- F-07-04 AOA/OHF Fellowship
- Acronym
- SOMMA
- Status last verified
- Jun 2010
- First submitted
- 30 Jun 2008
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Osteopathic Manipulation in the Management of Angina
- ClinicalTrials.gov ID
- NCT00708279
- Acronym / sponsor ID
- SOMMA / F-07-04 SOMMA
- Conditions
- Angina Pectoris
- Keywords
- angina pectoris, osteopathic manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Collaborators
- Osteopathic Heritage Foundations
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jul 2008 (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 purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Osteopathic manipulationAfter establishing a baseline for the first 4 weeks of trial involvement, thereby providing their own control group, all participants begin the intervention phase of osteopathic manipulation. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Canadian Cardiovascular Society Class II, III for a minimum of 6 months
- documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel.
Key exclusion criteria (11 listed)
- severe left ventricular dysfunction
- symptomatic heart failure
- symptomatic aortic stenosis or any valvular disease
- significant pulmonary disease
- unstable angina
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 |
|---|---|---|
| Osteopathic manipulationAlso: osteopathic manipulative medicine, structural exam, viscero-somatic reflexes, circulatory-respirtatory modelParticipant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months. | Procedure or surgery | A |
Primary outcome
Decrease in angina symptoms
Time frame: over 4 month period
1 secondary outcome
Improvement in quality of life
Time frame: over 4 month period
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 14 Apr 2011.
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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.
Joy L. Palmer, D.O. principal investigator
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulation in people with Angina Pectoris, run by University of New England 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 2 inclusion and 11 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 14 Apr 2011. 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. 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 angina symptoms (time frame: over 4 month period). 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 14 Apr 2011.