Trial Outcomes & Findings for Study of Arm and Putter Movement in Golfers With Golfer's Cramp (NCT NCT02032758)
NCT ID: NCT02032758
Last Updated: 2016-07-25
Results Overview
"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.
COMPLETED
PHASE4
38 participants
baseline, approximately 45 minutes after propranolol dosing
2016-07-25
Participant Flow
Subjects were recruited from Mayo Clinic in Arizona.
Participant milestones
| Measure |
Golfers With Golfer's Cramp
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.
|
Golf Pros
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
11
|
|
Overall Study
COMPLETED
|
27
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Arm and Putter Movement in Golfers With Golfer's Cramp
Baseline characteristics by cohort
| Measure |
Golfers With Golfer's Cramp
n=27 Participants
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.
|
Golf Pros
n=11 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
11 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, approximately 45 minutes after propranolol dosingPopulation: This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.
"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.
Outcome measures
| Measure |
Golfers With Golfer's Cramp
n=27 Participants
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.
|
Golf Pros
n=11 Participants
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.
|
|---|---|---|
|
Mean Dynamic Change of Rotation at Impact
No propranolol
|
-38.4 degrees/sec
Standard Deviation 26.1
|
-32.5 degrees/sec
Standard Deviation 9.8
|
|
Mean Dynamic Change of Rotation at Impact
After propranolol
|
-36.5 degrees/sec
Standard Deviation 36.5
|
NA degrees/sec
Standard Deviation NA
The pro golfers did not take propranolol so they were only tested once, at baseline.
|
SECONDARY outcome
Timeframe: baseline, approximately 45 minutes after propranolol dosingPopulation: This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.
"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.
Outcome measures
| Measure |
Golfers With Golfer's Cramp
n=27 Participants
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.
|
Golf Pros
n=11 Participants
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.
|
|---|---|---|
|
Mean Total Putter Face Rotation Before Impact
After propranolol
|
3.4 degrees
Standard Deviation 1.9
|
NA degrees
Standard Deviation NA
The pro golfers did not take propranolol so they were only tested once, at baseline.
|
|
Mean Total Putter Face Rotation Before Impact
No propranolol
|
3.3 degrees
Standard Deviation 1.3
|
3.1 degrees
Standard Deviation 0.6
|
Adverse Events
Golfers With Golfer's Cramp
Golf Pros
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place