HealthyNCT00958646
Biomarkers of the Response to Osteopathic Manipulation
A study testing Osteopathic Manipulation in people with Healthy, run by West Virginia School of Osteopathic Medicine at 1 site in United States.
Trial summary
The purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT). Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Osteopathic Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2010
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between the ages of 21 and 60
Who cannot join
- Eating or drinking anything but water or chewing gum within an hour of the appointment
- Rib fracture
- History of unstable cardiac arrhythmia or symptoms related to the chest cavity (difficulty breathing, chest pain)
- Symptoms suggestive of bowel obstruction (abdominal bloating with pain, nausea and vomiting, diarrhea)
- Pregnancy
- History of Sjogren's Syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, 24901
About this study
Official title: Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment
The purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT).
- Conditions
- Healthy
- Being tested
- Osteopathic Manipulation, Placebo
- Keywords
- OMT, biomarker, Manipulation, osteopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic ManipulationOther
Standardized rib raising protocol
PlaceboOther
Light touch control procedure
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulation | Experimental | Standardized OMT procedure Receives: Other: Osteopathic Manipulation |
| Placebo | Placebo comparator | Light touch placebo procedure Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary amylase levels
Measured: baseline, 10 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia School of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Investigators
- Kristie G Bridges, PhD, Principal investigator, West Virginia School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958646
- Sponsor's protocol ID
- KB081209
- Other IDs
- 09-12-580
- Status last verified
- Jul 2011
- First submitted
- 12 Aug 2009
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment
- ClinicalTrials.gov ID
- NCT00958646
- Acronym / sponsor ID
- KB081209
- Conditions
- Healthy
- Keywords
- OMT, biomarker, Manipulation, osteopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- West Virginia School of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Aug 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 purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulation | Experimental | Other: Osteopathic ManipulationStandardized OMT procedure |
| Placebo | Placebo comparator | Other: PlaceboLight touch placebo procedure |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults between the ages of 21 and 60
Key exclusion criteria (6 listed)
- Eating or drinking anything but water or chewing gum within an hour of the appointment
- Rib fracture
- History of unstable cardiac arrhythmia or symptoms related to the chest cavity (difficulty breathing, chest pain)
- Symptoms suggestive of bowel obstruction (abdominal bloating with pain, nausea and vomiting, diarrhea)
- Pregnancy
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 ManipulationStandardized rib raising protocol | Other | Osteopathic Manipulation |
| PlaceboLight touch control procedure | Other | Placebo |
Primary outcome
Salivary amylase levels
Time frame: baseline, 10 minutes post procedure
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 13 Jul 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.
Kristie G Bridges, PhD principal investigator
West Virginia School of Osteopathic Medicine
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 Healthy, run by West Virginia School of Osteopathic Medicine 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 1 inclusion and 6 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 13 Jul 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. 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?
Salivary amylase levels (time frame: baseline, 10 minutes post procedure). 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 13 Jul 2011.