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临床试验/NCT04789811
NCT04789811Unknown不适用

The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps

Kars State Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Change in cramp intensity levels with visual analog scale

研究概览

简要总结

The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.

详细描述

Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
接受健康志愿者

入选标准

  • Patients with only nocturnal calf cramp
  • Patients with a trigger point in the unilateral gastrocnemius muscle
  • Being between the ages of 18-50

排除标准

  • Patients using diuretics or hypertension medications that may trigger cramping
  • Those with a chronic disease history
  • Those diagnosed with spinal stenosis
  • Electrolyte disturbance in laboratory tests

结局指标

主要结局

Change in cramp intensity levels with visual analog scale

时间窗: 3 months

How intense the cramp felt by the patient was recorded with a visual analog scale. The score is between 0 to 10, and higher values represent a worse outcome.

Change in algometric sensitivity measurement

时间窗: 3 months

Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.

Change in Number of Cramps

时间窗: 3 months

How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome

Change in calf cramp duration

时间窗: 3 months

How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome

Change in sleep quality

时间窗: 3 months

The sleep quality of the patients was evaluated with the Pittsburgh Sleep Quality index. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

次要结局

未报告次要终点

研究者

发起方
Kars State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Bagcier

Principal Investigator

Kars State Hospital

研究点 (1)

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