Palmaris Longus Muscle and Dupuytren (Palmaris)
The Potential Relationship Between the Palmaris Longus Muscle Prevalence and Dupuytren Disease: a Comparative Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ilse Degreef, Prof. Dr.
- Phone Number: +32 16 33 88 43
- Email: ilse.degreef@uzleuven.be
Study Contact Backup
- Name: Anna Tarasiuk
- Phone Number: +32 16 33 88 18
- Email: orthopedie.research@uzleuven.be
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- Universitaire Ziekenhuizen KU Leuven
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ilse Degreef, Prof. Dr., Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- S68374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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