Flexor Tendons InjuriesNCT06410339
Ultrasound Assessment of Anatomical Changes in the Fingers of Recreational Rock Climbers
An observational study of Flexor Tendons Injuries, run by Rocky Vista University, LLC at 1 site in United States.
Trial summary
The objective of this study is to assess whether recreational rock climbers experience thickening of the flexor digitorum tendon in the 2nd 3rd and 4th fingers. In these fingers the study will also assess whether there is thickening of the A2 annular pulley and if there is a measurable increase in the tendon to bone… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexor Tendons Injuries
- What is being tested?
- Ultrasound
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy 18-40 year olds
Who may be able to join
- Able to hold finger still for ultrasound measurement
Who cannot join
- Previous ligamentous or tendinous injury in the fingers being tested
- Connective tissue disorder
- Condition affecting the structure or function of their fingers.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rocky Vista University
Parker, Colorado, 80112
Kathryn Vidlock, MD, 651-226-1642, kvidlock@rvu.edu
Gavin Kirby, BA
About this study
The objective of this study is to assess whether recreational rock climbers experience thickening of the flexor digitorum tendon in the 2nd 3rd and 4th fingers. In these fingers the study will also assess whether there is thickening of the A2 annular pulley and if there is a measurable increase in the tendon to bone distance at the level of the A2 pulley when the fingers are placed into flexion against mild resistance. This study aims to provide clinicians with an understanding of how exposure to rock climbing can lead to chronic anatomical changes to the soft tissue structures of the finger. These changes have been demonstrated in the elite rock climber population, but have yet to be studied in the much larger and growing recreational rock climbing population which consisted of nearly 10 million participants in 2021. If significant, these anatomical variations might guide the assessment of imaging and clinical decision making when managing finger injuries in patients with exposure to rock climbing. Portable ultrasound probes will be used to scan and measure the dimensions of various soft tissue structures in the hands of both rock climbers and a control population, this data will be paired with data collected in a brief survey asking about exposure to rock climbing, history of finger injuries, and style of climbing.
Read the 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)
- Conditions
- Flexor Tendons Injuries
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
ultrasound of flexor tendons on hands
| Study group | Role | What they receive |
|---|---|---|
| rock climbers | rock climbers of varying experience levels 18-40 years old Receives: Diagnostic Test: Ultrasound | |
| control | non rock climbers 18-40 years old Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injuries to finger, specifically flexor tendon
Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start29 Apr 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Flexor Tendons InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rocky Vista University, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410339
- Sponsor's protocol ID
- 2022-195
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon request at this time
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.
PubMed 10569358El-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.
PubMed 19554140Schoffl 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.
PubMed 31705177
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Anatomical Changes in the Fingers of Recreational Rock Climbers
- ClinicalTrials.gov ID
- NCT06410339
- Acronym / sponsor ID
- 2022-195
- Conditions
- Flexor Tendons Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rocky Vista University, LLCUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess whether recreational rock climbers experience thickening of the flexor digitorum tendon in the 2nd 3rd and 4th fingers. In these fingers the study will also assess whether there is thickening of the A2 annular pulley and if there is a measurable increase in the tendon to bone distance at the level of the A2 pulley when the fingers are placed into flexion against mild resistance. This study aims to provide clinicians with an understanding of how exposure to rock climbing can lead to chronic anatomical changes to the soft tissue structures of the finger. These changes have been demonstrated in the elite rock climber population, but have yet to be studied in the much larger and growing recreational rock climbing population which consisted of nearly 10 million participants in 2021. If significant, these anatomical variations might guide the assessment of imaging and clinical decision making when managing finger injuries in patients with exposure to rock climbing. Portable ultrasound probes will be used to scan and measure the dimensions of various soft tissue structures in the hands of both rock climbers and a control population, this data will be paired with data collected in a brief survey asking about exposure to rock climbing, history of finger injuries, and style of climbing.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rock climbers | – | Diagnostic Test: Ultrasoundrock climbers of varying experience levels 18-40 years old |
| control | – | Diagnostic Test: Ultrasoundnon rock climbers 18-40 years old |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy 18-40 year olds
Key inclusion criteria (1 listed)
- Able to hold finger still for ultrasound measurement
Key exclusion criteria (4 listed)
- Previous ligamentous or tendinous injury in the fingers being tested
- Connective tissue disorder
- Condition affecting the structure or function of their fingers.
- Pregnancy
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 |
|---|---|---|
| Ultrasoundultrasound of flexor tendons on hands | Diagnostic test | control, rock climbers |
Primary outcome
Injuries to finger, specifically flexor tendon
Time frame: 1 year
Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 10569358Klauser 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.
- Background: PubMed 19554140El-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.
- Background: PubMed 31705177Schoffl 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.
- Individual participant dataSharing planned: Undecided. Available upon request at this time
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flexor Tendons Injuries, run by Rocky Vista University, LLC 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 May 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injuries to finger, specifically flexor tendon (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410339, which also lists 3 linked publications.
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 13 May 2024.