- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06281509
Palmaris Longus Muscle and Dupuytren (Palmaris)
March 6, 2026 updated by: Universitaire Ziekenhuizen KU Leuven
The Potential Relationship Between the Palmaris Longus Muscle Prevalence and Dupuytren Disease: a Comparative Study
Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand.
Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand.
This fascia is seen as the vestigial remnant of the palmaris longus tendon.
The PLM attaches to the fascia palmaris.
A muscle that not everyone has and can therefore be clearly missed.
This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures.
To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition.
Study Overview
Status
Completed
Conditions
Detailed Description
Dupuytren disease is also known as Dupuytren contracture.
It is a medical condition characterized by the painless formation of nodules in the palm of the hand.
As the disease progresses, approximately 21% - 50% of all patients experience a transformation of these nodules (stage 0/N of Tubiana) into cord-like structures.
These cords, in turn, lead to finger contractures (Tubiana stages 1-4) with impairment of hand mobility and stiffening of the palmar skin.
The cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand.
This fascia is seen as the vestigial remnant of the palmaris longus tendon.
The PLM attaches to the fascia palmaris.
A muscle that not everyone has and can therefore be clearly missed.
This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures.
To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition.
Interestingly, prior research has already explored this topic.
Despite the publication dating back to 1986, it reported a significantly higher occurrence of the palmaris longus tendon in patients affected by DD.
Furthermore, a second article from the same year concluded a significant decrease in recurrence when the palmaris longus tendon was resected in combination with regional fasciectomy.
Remarkably, no other research on this topic was found despite the promising results of both articles.
Study Type
Interventional
Enrollment (Actual)
243
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 Locations
-
-
Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Universitaire Ziekenhuizen KU Leuven
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment.
- 50 years of age or higher.
- Has Dupuytren disease (primary or recurrent). (Only applicable for participants of DD group)
- Has no medical conditions affecting the function of the hand (musculoskeletal pathology, vascular or neurological conditions such as CRPS, rheumatoid arthritis and paralysis). (Only applicable for participants of control group)
Exclusion Criteria:
- Patients < 50 years
- Patients with cognitive impairments.
- Patients showing signs of medical conditions affecting the function of the hand (musculoskeletal pathology, vascular or neurological conditions such as CRPS, rheumatoid arthritis and paralysis). (Only applicable for participants of control group)
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with Dupuytren disease
120 individuals diagnosed with Dupuytren disease (primary or recurrent).
|
Schaeffer's test (flexion of the wrist while the pinky and thumb are pressed against each other) Thompson's test (wrist flexion with a clenched fist) Mishra test I (wrist flexion while the examiner pushes the hand back) Mashra test II (thumb opposition while flexing the wrist)
A small mobile ultrasound device will be used to further asses the presence of the tendon.
|
|
Experimental: Healthy controls
120 participants with no other medical conditions affecting the function of the hand (musculoskeletal pathology, vascular or neurological conditions such as CRPS, rheumatoid arthritis and paralysis).
|
Schaeffer's test (flexion of the wrist while the pinky and thumb are pressed against each other) Thompson's test (wrist flexion with a clenched fist) Mishra test I (wrist flexion while the examiner pushes the hand back) Mashra test II (thumb opposition while flexing the wrist)
A small mobile ultrasound device will be used to further asses the presence of the tendon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PLM in the DD versus control
Time Frame: Baseline
|
Percentual prevalence of the Palmaris Longus Muscle in the Dupuytren Disease-group versus the control group.
|
Baseline
|
|
PML in mild versus severe DD-group
Time Frame: Baseline
|
Percentual prevalence of the Palmaris Longus Muscle in the mild (stage 0/N of Tubiana) Dupuytren Disease-group versus the severe (Tubiana stages 1-4) Dupuytren Disease-group.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PLM presence in DD affected group
Time Frame: Baseline
|
Percentual prevalence of the Palmaris Longus Muscle in the Dupuytren Disease-group
|
Baseline
|
|
PLM presence in control group
Time Frame: Baseline
|
Percentual prevalence of the Palmaris Longus Muscle in the control group
|
Baseline
|
|
Dominant versus non-dominant hand
Time Frame: Baseline
|
Percentual prevalence of the Palmaris Longus Muscle in the dominant hand versus the non-dominant hand for both Dupuytren Disease-group and control group.
|
Baseline
|
|
Male versus female population
Time Frame: Baseline
|
Percentual prevalence of the Palmaris Longus Muscle in male versus female population.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ilse Degreef, Prof. Dr., Universitaire Ziekenhuizen KU Leuven
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)
February 16, 2024
Primary Completion (Actual)
November 28, 2025
Study Completion (Actual)
November 28, 2025
Study Registration Dates
First Submitted
February 19, 2024
First Submitted That Met QC Criteria
February 26, 2024
First Posted (Actual)
February 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 9, 2026
Last Update Submitted That Met QC Criteria
March 6, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Neoplasms
- Connective Tissue Diseases
- Neoplasms by Histologic Type
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Connective Tissue
- Neoplasms, Fibrous Tissue
- Fibroma
- Contracture
- Skin and Connective Tissue Diseases
- Dupuytren Contracture
- Physical Phenomena
- Radiation
- Radiation, Nonionizing
- Ultrasonic Waves
- Sound
- High-Energy Shock Waves
Other Study ID Numbers
- S68374
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
product manufactured in and exported from the U.S.
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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