NCT03241095

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

July 27, 2017

Last Update Submit

July 15, 2020

Conditions

Keywords

Osteopathic Manipulation TreatmentGolf

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 minutes

Study Arms (3)

Control

NO INTERVENTION

Sham OMT

SHAM COMPARATOR
Procedure: Sham intervention

OMT

ACTIVE COMPARATOR
Procedure: OMT (Osteopathic Manipulative Treatment)

Interventions

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.

OMT

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.

Sham OMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Health System - Family Medicine Clinic

Mankato, Minnesota, 56001, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Angela Buffington, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 7, 2017

Study Start

August 17, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations