NCT02032758

Brief Summary

The investigators will investigate golfers with visual evidence of an involuntary movement while putting before and after treatment with a low dose of propranolol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 25, 2016

Completed
Last Updated

July 25, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

January 2, 2014

Results QC Date

May 5, 2016

Last Update Submit

June 10, 2016

Conditions

Occupational; Cramp(s)

Keywords

Occupational; Cramp(s)

Outcome Measures

Primary Outcomes (1)

  • Mean Dynamic Change of Rotation at Impact

    "Dynamic change of rotation at impact" is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.

    baseline, approximately 45 minutes after propranolol dosing

Secondary Outcomes (1)

  • Mean Total Putter Face Rotation Before Impact

    baseline, approximately 45 minutes after propranolol dosing

Study Arms (2)

Golfers With Golfer's Cramp

EXPERIMENTAL

Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.

Drug: PropranololDevice: Opal DeviceProcedure: Science and Motion PuttLab (SAM)Device: Surface Electromyography EMG

Golf Pros

OTHER

Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.

Device: Opal DeviceProcedure: Science and Motion PuttLab (SAM)Device: Surface Electromyography EMG

Interventions

PropranololDRUG

Single oral dose of 10 mg propranolol

Also known as: Inderal
Golfers With Golfer's Cramp
Opal DeviceDEVICE

The Opal Device (APDM, Inc.) will be used to measure wrist movement.

Golf ProsGolfers With Golfer's Cramp
Science and Motion PuttLab (SAM)PROCEDURE

The SAM will be used to study putter stroke movement and ball movement.

Golf ProsGolfers With Golfer's Cramp
Surface Electromyography EMGDEVICE

The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.

Golf ProsGolfers With Golfer's Cramp

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75
  • Complaint of golfer's cramp/yips
  • Visual evidence of a movement disorder during putting
  • Able to complete 80 putts during the session

You may not qualify if:

  • Contraindication to treatment with propranolol
  • Movement disorder not when putting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Dystonic Disorders

Interventions

PropranololElectromyography

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Results Point of Contact

Title
Dr. Charles H. Adler
Organization
Mayo Clinic in Arizona
cadler@mayo.edu
480-301-8100

Study Officials

  • Charles Adler, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurolgy

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 25, 2016

Results First Posted

July 25, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)