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临床试验/NCT06394310
NCT06394310招募中不适用

The Effectiveness of Dry Needling on Reducing Spasticity and Promoting Mobility and Balance in People With Multiple Sclerosis

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Spasticity

研究概览

简要总结

The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 to 64 years
  • •Clinical diagnosis of Multiple Sclerosis based on the McDonald Criteria
  • •Spasticity in their lower legs
  • •Patient Determined Disease Steps (PDDS) score of 5 or below

排除标准

  • •Inability to communicate effectively with study personnel
  • •Needle phobia
  • •Severe varicose veins
  • •Presence of an active implanted device
  • •Pregnancy
  • •Any active cancer or history within 1 year
  • •known or suspected infection at the site of needling or in the surrounding area
  • •Presence of a fixed plantarflexion contracture at the ankle
  • •Acute fracture of dislocation in the region (bilateral lower extremity)
  • •Deep vein thrombosis or peripheral vascular disease
  • •Thrombophlebitis, or active osteomyelitis in the region (bilateral lower extremity)
  • •Any medication changes, including antispastic medicines, for the past three months.

研究组 & 干预措施

Dry needling

Experimental

Participants will complete three sessions of dry needling through three weeks (one session per each week)

干预措施: Dry needling (Device)

Sham DN

Sham Comparator

Participants randomized to the control group will be receiving sham needling

干预措施: Sham dry needling (Device)

结局指标

主要结局

Spasticity

时间窗: 5 weeks

Spasticity will be assessed through the Modified Ashworth scale (Scored between 0 to 4, with higher scores show higher level of spasticity)

次要结局

未报告次要终点

研究者

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

Jacob J. Sosnoff, Ph.D.

Principal Investigator

University of Kansas Medical Center

研究点 (1)

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