- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410339
Ultrasound Assessment of Anatomical Changes in the Fingers of Recreational Rock Climbers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to assess whether there in an increase in the diameter of the flexor digitorum tendon, an increase in thickness of the A2 annular pulley, and the tendon to bone distance at the A2 pulley in recreational rock climbers when compared to the general population when assessed using sonography. Recreational rock climbing is an emerging sport with more than 10 million estimated participants in the United States alone. Point of care ultrasound is a common, affordable modality to assess finger injuries and is being used commonly by sports medicine physicians globally. Measuring the ligamentous tendinous structures in the fingers is one technique used to assess inflammation or degeneration of these structures. It has been demonstrated that there are significant anatomical differences present in a population of elite-level rock climbers, but this has not yet been assessed in the much larger recreational climbing population. If this study can demonstrate that recreational rock climbers display similar anatomical changes, sports medicine physicians might consider whether or not their patient has significant exposure to this activity when assessing these structures. This study will use high frequency ultrasound (12MHz) to assess anatomic landmarks in the fingers of study participants. All data will be de identified. Statistical analysis will involve a variety of modalities including T-test, Chi square analysis and ANOVA. The data collected will be de-identified using a participant number and stored separately from all identifying data. Data will be stored in a password protected OneDrive file. Participant information will be stored in a separate password protected OneDrive file. All researchers will have access to the data collected for data analysis. Dr. Vidlock alone will have access to the participant identifying data. Data with subject identifiers will not be released to other individuals or agencies. Data collection for the experimental group in this study will be conducted at the Ubergrippen Indoor Climbing Crag in Denver, CO. Data collection for the control group in the study will be conducted at the RVU Colorado campus. Ultrasound images taken of the flexor digitorum tendon in the 2nd, 3rd, and 4th fingers will be measured onsite immediately after data collection is completed. The study will be completed in a single sitting taking approximately 10 minutes to capture ultrasound images of the 3 digits on each hand. Participants will then complete a survey that should take no longer than 10 minutes to complete. Participants will be invited to voluntary participate until approximately 25 climbers, and 25 control subjects have been assessed. Participants must be between 18-40 years old. All participants must participate in some form of exercise 2-5x per week on average. Participants will be excluded if they have been diagnosed with a ligamentous or tendinous injury in the fingers being tested. Participants will be excluded if they have a diagnosed connective tissue disorder, or any other condition affecting the structure or function of their fingers. Patients who are known to be pregnant will be excluded. Participants must be between 18-40 years old. All participants must participate in some form of exercise 2-5x per week on average. Participants will be excluded if they have been diagnosed with a ligamentous or tendinous injury in the fingers being tested. Participants will be excluded if they have a diagnosed connective tissue disorder, or any other condition affecting the structure or function of their fingers. Patients who are known to be pregnant will be excluded.
The climber group subjects must have at least 6 contiguous months of climbing experience and climb more than 2x but less than 4x per week.
The control group must have no consistent climbing experience. (less than 3x in the past 6 months, less than 10x total)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Colorado
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Parker, Colorado, United States, 80112
- Recruiting
- Rocky Vista University
-
Contact:
- Kathryn Vidlock, MD
- Phone Number: 651-226-1642
- Email: kvidlock@rvu.edu
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Principal Investigator:
- Gavin Kirby, BA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
*Able to hold finger still for ultrasound measurement
Exclusion Criteria:
- Previous ligamentous or tendinous injury in the fingers being tested
- Connective tissue disorder
- Condition affecting the structure or function of their fingers.
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
rock climbers
rock climbers of varying experience levels 18-40 years old
|
ultrasound of flexor tendons on hands
|
control
non rock climbers 18-40 years old
|
ultrasound of flexor tendons on hands
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Injuries to finger, specifically flexor tendon
Time Frame: 1 year
|
Questionnaire
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Klauser A, Bodner G, Frauscher F, Gabl M, Zur Nedden D. Finger injuries in extreme rock climbers. Assessment of high-resolution ultrasonography. Am J Sports Med. 1999 Nov-Dec;27(6):733-7. doi: 10.1177/03635465990270060801.
- El-Sheikh Y, Wong I, Farrokhyar F, Thoma A. Diagnosis of finger flexor pulley injury in rock climbers: A systematic review. Can J Plast Surg. 2006 Winter;14(4):227-31. doi: 10.1177/229255030601400405.
- Schoffl V, Simon M, Lutter C. [Finger and shoulder injuries in rock climbing]. Orthopade. 2019 Dec;48(12):1005-1012. doi: 10.1007/s00132-019-03825-3. German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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