- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694078
Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers
January 11, 2023 updated by: Hand Therapy Barcelona
This study aimes to analyze the effectiveness of a Hand Therapy protocol in the management of patients who suffer from a tear of a lumbrical muscle, regarding on the symptoms during the clinical examination, the disability in their activities of daily living and the sports-specific function.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A prospective intervention study is performed on 50 adult climbers suffering from an injury of the 4th lumbrical muscle.
They wear during 3 weeks a 5th finger extension relative motion orthosis, while pain-free sport activities are permitted using a 4th and 5th fingers buddy-taping.
After three weeks, patients are told to progressively remove the splint and, after six weeks, the splint is totally removed.
Symptoms in the lumbrical stress test are evaluated during the 6 weeks period using dynamometry and goniometry, Finally, Quick-Disabilities of the arm shoulder and hand questionnaire is also analyzed.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Núria Carnicero
- Phone Number: +34659105330
- Email: nu.carnicero@gmail.com
Study Locations
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08010
- Recruiting
- Hand Therapy Barcelona
-
Contact:
- Vicenç Punsola-Izard
- Phone Number: 34-933013929
- Email: fisioterapia.punsola@gmail.com
-
Contact:
- Núria Carnicero
- Email: nu.carnicero@gmail.com
-
Principal Investigator:
- Núria Carnicero, PhDC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult climbers suffering from an injury of the 4th lumbrical muscle
Exclusion Criteria:
- Patients with previous treatments.
- Patients with concomitant injuries or illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lumbrical Injured Climbers
6-weeks relative motion splinting protocol, while pain-free sport activities are permitted
|
Relative motion splinting protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dinamometry in lumbrical stress test
Time Frame: It will be evaluated at 6 weeks
|
Symptoms in the lumbrical stress test will be evaluated during the 6 weeks period using an adapted Jamar handgrip dynamometer on a climbing hold.
The climber is told to pull on the hold until the pain starts.
|
It will be evaluated at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goniometry in lumbrical stress test
Time Frame: It will be evaluated at 6 weeks
|
Finger flexion metacarpophalangeal joint goniometry of the 5th finger is measured during the lumbrical stress test when pain appears
|
It will be evaluated at 6 weeks
|
Quick-Disabilities of the arm shoulder and hand questionnaire
Time Frame: It will be evaluated at 6 weeks
|
Participants will be asked to answer "Quick-Disabilities of the arm shoulder and hand" questionnaire before the clinical examination.
In "Quick-Disabilities of the arm shoulder and hand" each item has response options and, from the item scores, scale scores are calculated, raning from o (no disability) to 100 (most severe disability).
|
It will be evaluated at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Núria Carnicero, Hand Therapy Barcelona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lutter C, Schweizer A, Schoffl V, Romer F, Bayer T. Lumbrical muscle tear: clinical presentation, imaging findings and outcome. J Hand Surg Eur Vol. 2018 Sep;43(7):767-775. doi: 10.1177/1753193418765716. Epub 2018 Mar 28.
- Schweizer A. Lumbrical tears in rock climbers. J Hand Surg Br. 2003 Apr;28(2):187-9. doi: 10.1016/s0266-7681(02)00250-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 23, 2022
Primary Completion (Anticipated)
February 28, 2023
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
December 23, 2022
First Submitted That Met QC Criteria
January 11, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 11, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lumbrical
- PhD University Program (Other Identifier: Universitat Autonoma de Barcelona)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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