跳至主要内容
临床试验/NCT06281509
NCT06281509已完成不适用

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

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2024年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
243
试验地点
1
主要终点
PLM in the DD versus control

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

No masking will be done in this study

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

Patients with Dupuytren disease

Experimental

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

干预措施: Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands. (Procedure)

Patients with Dupuytren disease

Experimental

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

干预措施: Ultrasound (Procedure)

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).

干预措施: Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands. (Procedure)

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).

干预措施: Ultrasound (Procedure)

结局指标

主要结局

PLM in the DD versus control

时间窗: Baseline

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

PML in mild versus severe DD-group

时间窗: 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.

次要结局

  • Dominant versus non-dominant hand(Baseline)
  • Male versus female population(Baseline)
  • PLM presence in DD affected group(Baseline)
  • PLM presence in control group(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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