Muscle TearNCT05694078
Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers
A study testing Hand Therapy Splinting Protocol in people with Muscle Tear and Hand Injuries, run by Hand Therapy Barcelona at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Tear, Hand Injuries, Splints
- What is being tested?
- Hand Therapy Splinting Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 23 Dec 2022to 31 Mar 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult climbers suffering from an injury of the 4th lumbrical muscle
Who cannot join
- Patients with previous treatments.
- Patients with concomitant injuries or illness
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hand Therapy Barcelona
Barcelona, Catalonia, 08010
Vicenç Punsola-Izard, 34-933013929, fisioterapia.punsola@gmail.com
Núria Carnicero, nu.carnicero@gmail.com
About this study
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.
Read the 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.
- Conditions
- Muscle Tear, Hand Injuries, Splints
- Being tested
- Hand Therapy Splinting Protocol
- Keywords
- Lumbrical, Sport Climbing, Hand Therapy, Hand Injuries, Relative Motion
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Therapy Splinting ProtocolOther
Also called Relative Motion
Relative motion splinting protocol
| Study group | Role | What they receive |
|---|---|---|
| Lumbrical Injured Climbers | Experimental | 6-weeks relative motion splinting protocol, while pain-free sport activities are permitted Receives: Other: Hand Therapy Splinting Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dinamometry in lumbrical stress test
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.
Measured: It will be evaluated at 6 weeks
Secondary outcomes (2)
Goniometry in lumbrical stress test
Finger flexion metacarpophalangeal joint goniometry of the 5th finger is measured during the lumbrical stress test when pain appears
Measured: It will be evaluated at 6 weeks
Quick-Disabilities of the arm shoulder and hand questionnaire
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).
Measured: It will be evaluated at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start23 Dec 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle TearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hand Therapy Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Núria Carnicero, Principal investigator, Hand Therapy Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694078
- Sponsor's protocol ID
- Lumbrical
- Other IDs
- PhD University Program
- Status last verified
- Jan 2023
- First submitted
- 23 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29591320Schweizer A. Lumbrical tears in rock climbers. J Hand Surg Br. 2003 Apr;28(2):187-9. doi: 10.1016/s0266-7681(02)00250-4.
PubMed 12631495
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Therapy Approach on Lumbrical Muscle Tears in Sport Climbers
- ClinicalTrials.gov ID
- NCT05694078
- Acronym / sponsor ID
- Lumbrical
- Conditions
- Muscle Tear, Hand Injuries, Splints
- Keywords
- Lumbrical, Sport Climbing, Hand Therapy, Hand Injuries, Relative Motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hand Therapy BarcelonaUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 23 Jan 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbrical Injured Climbers | Experimental | Other: Hand Therapy Splinting Protocol6-weeks relative motion splinting protocol, while pain-free sport activities are permitted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult climbers suffering from an injury of the 4th lumbrical muscle
Key exclusion criteria (2 listed)
- Patients with previous treatments.
- Patients with concomitant injuries or illness
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 |
|---|---|---|
| Hand Therapy Splinting ProtocolAlso: Relative MotionRelative motion splinting protocol | Other | Lumbrical Injured Climbers |
Primary outcome
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.
2 secondary outcomes
Goniometry in lumbrical stress test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Background: PubMed 29591320Lutter 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.
- Background: PubMed 12631495Schweizer A. Lumbrical tears in rock climbers. J Hand Surg Br. 2003 Apr;28(2):187-9. doi: 10.1016/s0266-7681(02)00250-4.
- Individual participant dataSharing planned: No
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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.
Núria Carnicero principal investigator
Hand Therapy Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Therapy Splinting Protocol in people with Muscle Tear and Hand Injuries, run by Hand Therapy Barcelona at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. 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 Spain. 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?
Contact Núria Carnicero (+34659105330, nu.carnicero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dinamometry in lumbrical stress test (time frame: It will be evaluated at 6 weeks). 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 NCT05694078, which also lists 2 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 23 Jan 2023.