Occupational; Cramp(s)Phase 4NCT02032758
Study of Arm and Putter Movement in Golfers With Golfer's Cramp
A Phase 4 study testing Propranolol, Opal Device and Science and Motion PuttLab (SAM) in people with Occupational; Cramp(s), run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational; Cramp(s)
- What is being tested?
- Propranolol, Opal Device and Science and Motion PuttLab (SAM)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to treatment with propranolol
- Movement disorder not when putting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Golfer's Cramp: Correlation of Wrist Movements and Surface EMG With Putter Movements
The investigators will investigate golfers with visual evidence of an involuntary movement while putting before and after treatment with a low dose of propranolol.
Read the 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.
- Conditions
- Occupational; Cramp(s)
- Being tested
- Propranolol, Opal Device, Science and Motion PuttLab (SAM), Surface Electromyography EMG
- Keywords
- Occupational; Cramp(s)
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Inderal
Single oral dose of 10 mg propranolol
Opal DeviceDevice
The Opal Device (APDM, Inc.) will be used to measure wrist movement.
Science and Motion PuttLab (SAM)Procedure or surgery
The SAM will be used to study putter stroke movement and ball movement.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propranolol; Device: Opal Device; Procedure: 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. Receives: Device: Opal Device; Procedure: Science and Motion PuttLab (SAM); Device: Surface Electromyography EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, approximately 45 minutes after propranolol dosing
Secondary outcomes (1)
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.
Measured: baseline, approximately 45 minutes after propranolol dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Occupational; Cramp(s)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Adler, Mayo Clinic
- Investigators
- Charles Adler, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032758
- Sponsor's protocol ID
- 12-007930
- Status last verified
- Jun 2016
- First submitted
- 2 Jan 2014
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golfer's Cramp: Correlation of Wrist Movements and Surface EMG With Putter Movements
- ClinicalTrials.gov ID
- NCT02032758
- Acronym / sponsor ID
- 12-007930
- Conditions
- Occupational; Cramp(s)
- Keywords
- Occupational; Cramp(s)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 25 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Golfers With Golfer's Cramp | Experimental | Drug: Propranolol, Device: Opal Device, Procedure: Science and Motion PuttLab (SAM), Device: Surface Electromyography EMGSubjects 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 | Other | Device: Opal Device, Procedure: Science and Motion PuttLab (SAM), Device: Surface Electromyography EMGSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to treatment with propranolol
- Movement disorder not when putting
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 |
|---|---|---|
| PropranololAlso: InderalSingle oral dose of 10 mg propranolol | Drug | Golfers With Golfer's Cramp |
| Opal DeviceThe Opal Device (APDM, Inc.) will be used to measure wrist movement. | Device | Golf Pros, Golfers With Golfer's Cramp |
| Science and Motion PuttLab (SAM)The SAM will be used to study putter stroke movement and ball movement. | Procedure or surgery | Golf Pros, Golfers With Golfer's Cramp |
| Surface Electromyography EMGThe surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups. | Device | Golf Pros, Golfers With Golfer's Cramp |
Primary outcome
Mean Dynamic Change of Rotation at Impact
Time frame: baseline, approximately 45 minutes after propranolol dosing
"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.
1 secondary outcome
Mean Total Putter Face Rotation Before Impact
Time frame: baseline, approximately 45 minutes after propranolol dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Charles Adler, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol, Opal Device and Science and Motion PuttLab (SAM) in people with Occupational; Cramp(s), run by Mayo Clinic 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 4 inclusion and 2 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 25 Jul 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Dynamic Change of Rotation at Impact (time frame: baseline, approximately 45 minutes after propranolol dosing). 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 25 Jul 2016.