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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06281509
Other study ID # S68374
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 16, 2024
Est. completion date February 1, 2025

Study information

Verified date February 2024
Source Universitaire Ziekenhuizen KU Leuven
Contact Ilse Degreef, Prof. Dr.
Phone +32 16 33 88 43
Email ilse.degreef@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Universitaire Ziekenhuizen KU Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary PLM in the DD versus control Percentual prevalence of the Palmaris Longus Muscle in the Dupuytren Disease-group versus the control group. Baseline
Primary 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 PLM presence in DD affected group Percentual prevalence of the Palmaris Longus Muscle in the Dupuytren Disease-group Baseline
Secondary PLM presence in control group Percentual prevalence of the Palmaris Longus Muscle in the control group Baseline
Secondary Dominant versus non-dominant hand 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
Secondary Male versus female population Percentual prevalence of the Palmaris Longus Muscle in male versus female population. Baseline
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