Manipulation, OsteopathicNCT03241095
The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Golf Swing
A study testing OMT (Osteopathic Manipulative Treatment) in people with Manipulation, Osteopathic, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of the study is to investigate if osteopathic manipulative treatment (OTM) improves the golf swing of the participants. Study participants will be randomized into three groups, we will stratify by age and gender to make them as uniform as possible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Manipulation, Osteopathic
- What is being tested?
- OMT (Osteopathic Manipulative Treatment)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2017to 31 May 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: Anyone under 18 years, people that do not golf.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System - Family Medicine Clinic
Mankato, Minnesota, 56001
About this study
Official title: The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Swing Via Objective Data From Golf Simulator Swing Analysis and Subjective Data
The purpose of the study is to investigate if osteopathic manipulative treatment (OTM) improves the golf swing of the participants. Study participants will be randomized into three groups, we will stratify by age and gender to make them as uniform as possible. One group will receive no intervention other than a 10-minute break between the pre and post measurements. A second group will receive a sham intervention where the doctor will pretend to give the participant OTM. The third group will receive real OTM.
Participants will perform a sample of 10 golf swings pre and post intervention which will be measured by a golf simulator. They will also complete a brief health history and pre/post self-evaluation of their swing.
- Conditions
- Manipulation, Osteopathic
- Being tested
- OMT (Osteopathic Manipulative Treatment), Sham intervention
- Keywords
- Osteopathic Manipulation Treatment, Golf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMT (Osteopathic Manipulative Treatment)Procedure or surgery
The co-hort will receive OMT. Each participant will perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. This co-hort will then be evaluated by the physician and be given OMT.
Sham interventionProcedure or surgery
The co-hort participants will each perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. Theythen be given a sham OMT procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Sham OMT | Sham comparator | Not described Receives: Procedure: Sham intervention |
| OMT | Active comparator | Not described Receives: Procedure: OMT (Osteopathic Manipulative Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of golf swing as measured by the carry distance (the distance the ball flies in the air)
The participant will perform 10 swings into a golf simulator using a 5 iron. The simulator will record the information for each swing. Measurements include: Club head speed (Mph), Ball speed (Mph), Launch angle (Deg), Azimuth (Deg), Side spin (Rpm), Back spin (Rpm), Total spin (Rpm), Descent angle (Deg), Carry (Yds),Total distance (Yds), Offline (Yds), Peak height (Yds). We will be looking at the 'Carry' variable, before and after the intervention.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start17 Aug 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manipulation, OsteopathicStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Buffington, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241095
- Sponsor's protocol ID
- FMCH-2017-25925
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Swing Via Objective Data From Golf Simulator Swing Analysis and Subjective Data
- ClinicalTrials.gov ID
- NCT03241095
- Acronym / sponsor ID
- FMCH-2017-25925
- Conditions
- Manipulation, Osteopathic
- Keywords
- Osteopathic Manipulation Treatment, Golf
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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 the study is to investigate if osteopathic manipulative treatment (OTM) improves the golf swing of the participants. Study participants will be randomized into three groups, we will stratify by age and gender to make them as uniform as possible. One group will receive no intervention other than a 10-minute break between the pre and post measurements. A second group will receive a sham intervention where the doctor will pretend to give the participant OTM. The third group will receive real OTM.
Participants will perform a sample of 10 golf swings pre and post intervention which will be measured by a golf simulator. They will also complete a brief health history and pre/post self-evaluation of their swing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Sham OMT | Sham comparator | Procedure: Sham intervention |
| OMT | Active comparator | Procedure: OMT (Osteopathic Manipulative Treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: Anyone under 18 years, people that do not golf.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OMT (Osteopathic Manipulative Treatment)The co-hort will receive OMT. Each participant will perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. This co-hort will then be evaluated by the physician and be given OMT. | Procedure or surgery | OMT |
| Sham interventionThe co-hort participants will each perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. Theythen be given a sham OMT procedure. | Procedure or surgery | Sham OMT |
Primary outcome
Strength of golf swing as measured by the carry distance (the distance the ball flies in the air)
Time frame: 30 minutes
The participant will perform 10 swings into a golf simulator using a 5 iron. The simulator will record the information for each swing. Measurements include: Club head speed (Mph), Ball speed (Mph), Launch angle (Deg), Azimuth (Deg), Side spin (Rpm), Back spin (Rpm), Total spin (Rpm), Descent angle (Deg), Carry (Yds),Total distance (Yds), Offline (Yds), Peak height (Yds). We will be looking at the 'Carry' variable, before and after the intervention.
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 17 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Angela Buffington, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT (Osteopathic Manipulative Treatment) in people with Manipulation, Osteopathic, run by University of Minnesota 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 0 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 17 Jul 2020. 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?
Strength of golf swing as measured by the carry distance (the distance the ball flies in the air) (time frame: 30 minutes). 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 17 Jul 2020.