Palmaris Longus Muscle and Dupuytren

NCT ID: NCT06281509

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dupuytren's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two groups: Patients with Dupuytren Disease and healthy control group. They will be age matched (50 years of age or higher) with the objective to have a proportionate division (50/50) between the genders.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking will be done in this study

Study Groups

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Patients with Dupuytren disease

120 individuals diagnosed with Dupuytren disease (primary or recurrent).

Group Type EXPERIMENTAL

Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands.

Intervention Type PROCEDURE

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)

Ultrasound

Intervention Type PROCEDURE

A small mobile ultrasound device will be used to further asses the presence of the tendon.

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).

Group Type EXPERIMENTAL

Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands.

Intervention Type PROCEDURE

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)

Ultrasound

Intervention Type PROCEDURE

A small mobile ultrasound device will be used to further asses the presence of the tendon.

Interventions

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Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands.

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)

Intervention Type PROCEDURE

Ultrasound

A small mobile ultrasound device will be used to further asses the presence of the tendon.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilse Degreef, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Ilse Degreef, Prof. Dr.

Role: CONTACT

+32 16 33 88 43

Anna Tarasiuk

Role: CONTACT

+32 16 33 88 18

Facility Contacts

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Ilse Degreef, Prof. Dr.

Role: primary

+32 16 33 88 43

Anna Tarasiuk

Role: backup

+32 16 33 88 18

Other Identifiers

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S68374

Identifier Type: -

Identifier Source: org_study_id

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