Palmaris Longus Muscle and Dupuytren

NCT06281509 | Completed

• 1 other identifier: S68374
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (2)

• PLM in the DD versus control

  Percentual prevalence of the Palmaris Longus Muscle in the Dupuytren Disease-group versus the control group.

  Baseline

• PML in mild versus severe DD-group

  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 Outcomes (4)

• PLM presence in DD affected group

  Baseline

• PLM presence in control group

  Baseline

• Dominant versus non-dominant hand

  Baseline

• Male versus female population

  Baseline

Study Arms (2)

Patients with Dupuytren disease

EXPERIMENTAL

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

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

Healthy controls

EXPERIMENTAL

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).

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

Interventions

Ultrasound PROCEDURE

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

Healthy controls; Patients with Dupuytren disease

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

Healthy controls; Patients with Dupuytren disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment.
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Ilse Degreef, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be done in this study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: February 16, 2024
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)