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Study of Arm and Putter Movement in Golfers With Golfer's Cramp

Primary Purpose

Occupational; Cramp(s)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Opal Device
Science and Motion PuttLab (SAM)
Surface Electromyography EMG
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Occupational; Cramp(s) focused on measuring Occupational; Cramp(s)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

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

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Golfers With Golfer's Cramp

Golf Pros

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Total Putter Face Rotation Before Impact
"Total putter face rotation before impact" is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.

Full Information

First Posted
January 2, 2014
Last Updated
June 10, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02032758
Brief Title
Study of Arm and Putter Movement in Golfers With Golfer's Cramp
Official Title
Golfer's Cramp: Correlation of Wrist Movements and Surface EMG With Putter Movements
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Dystonia affecting athletes has received little research attention and there has been a lack of awareness or interest among both physicians and athletes. Task-specific dystonias or occupational cramps affect people while writing, typing, and or playing a musical instrument. Our group has previously shown that a subset of golfers who complain of the yips appear to have a task-specific dystonia or golfer's cramp. The yips are characterized by an inability to appropriately complete a golf stroke, most often putting and chipping strokes. Most individuals with the yips describe a jerking or shaking movement that interrupts their swing. In many cases the yips are disabling and the golfer, including professional tour players, give up golfing. Golfers who have evidence of golfer's cramp will putt a series of putts during which they will be monitored for arm movements and putter movements. They will then be treated with a low dose of propranolol to see if there is a change in these parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational; Cramp(s)
Keywords
Occupational; Cramp(s)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Golfers With Golfer's Cramp
Arm Type
Experimental
Arm Description
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.
Arm Title
Golf Pros
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Inderal
Intervention Description
Single oral dose of 10 mg propranolol
Intervention Type
Device
Intervention Name(s)
Opal Device
Intervention Description
The Opal Device (APDM, Inc.) will be used to measure wrist movement.
Intervention Type
Procedure
Intervention Name(s)
Science and Motion PuttLab (SAM)
Intervention Description
The SAM will be used to study putter stroke movement and ball movement.
Intervention Type
Device
Intervention Name(s)
Surface Electromyography EMG
Intervention Description
The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.
Primary Outcome Measure Information:
Title
Mean Dynamic Change of Rotation at Impact
Description
"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.
Time Frame
baseline, approximately 45 minutes after propranolol dosing
Secondary Outcome Measure Information:
Title
Mean Total Putter Face Rotation Before Impact
Description
"Total putter face rotation before impact" is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.
Time Frame
baseline, approximately 45 minutes after propranolol dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: Contraindication to treatment with propranolol Movement disorder not when putting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Adler, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Arm and Putter Movement in Golfers With Golfer's Cramp

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