Palmaris Longus Muscle and Dupuytren

Dupuytren's Disease Clinical Trial

— Palmaris  

Official title:

The Potential Relationship Between the Palmaris Longus Muscle Prevalence and Dupuytren Disease: a Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281509
• Other study ID #: S68374
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

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