跳至主要内容
临床试验/NCT03722303
NCT03722303暂停早期 1 期

Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome

Columbia University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
暂停
入组人数
100
试验地点
1
主要终点
Functional Outcome Score

研究概览

简要总结

This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.

详细描述

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy affecting up to 13% of Americans; CTS is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness, pain, and tingling. Treatment options depend on the severity of symptoms and range from noninvasive options (most commonly, steroid injections) to definitive surgical release of the compressed median nerve. Both non-invasive techniques and surgical intervention have their shortcomings; thus a novel approach for CTS treatment may be indicated.

Lipografting is an established, validated, and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities. From observing these reconstructions, plastic surgeons have witnessed the regenerative properties of fat transfer, specifically delaying the affects of chronic radio-dermatitis. These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, the fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • primary mild to moderate carpal tunnel syndrome (CTS)
  • report symptoms longer than 6 months
  • night pain
  • sensory deficits
  • fluent English-speaking adult (>18)

排除标准

  • <18 years old
  • Non-english speaking
  • injection in past 6 months
  • previous hand surgery
  • previous hand trauma (fracture or dislocation)

研究组 & 干预措施

Steroid Injection

Active Comparator

Subjects with CTS will receive steroid injection.

干预措施: Steroid Injection (Drug)

Fat Injection

Experimental

Subjects with CTS will receive fat injection.

干预措施: Fat Injection (Other)

结局指标

主要结局

Functional Outcome Score

时间窗: Up to 1 year post-treatment

This score will be determined by Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH), which is a validated tool/survey for measuring upper extremity disability. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). These raw scores are used to calculate a score out of 100, with a higher score indicating greater disability.

次要结局

  • Score on the Brigham Women's Carpal Tunnel Questionnaire(Up to 1 year post-treatment)
  • Score on the Michigan Hand Questionnaire (MHQ)(Up to 1 year post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melvin Rosenwasser

Robert E. Carroll Professor of Hand Surgery, Columbia University Medical Center Attending Physician, Director of the Trauma Training Center, Director of Hand Fellowship

Columbia University

研究点 (1)

Loading locations...

相似试验