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临床试验/NCT05664165
NCT05664165已完成不适用

Can the Efficiency of Dry Needling and Cold Spray-stretching Treatments be Documented by Ultrasonography and Electrophysiology?

Haydarpasa Numune Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
pain intensity1

研究概览

简要总结

A prospective randomized single-blind study included 60 patients aged 18-65 years who have MPS with active triger points in the upper trapezius muscle. Patients were randomized into two treatment groups as dry needling (DN) and cold spray-stretching. Both treatment groups received 1 treatment per week and totally 3 sessions. Evaluation parameters were pain level assessed by visual analog scale (VAS) and algometer, neck range of motion angles, functional level assessed by neck disability index (NDI). The effects of the treatments on active trigger points were evaluated by sEMG and US histogram. All parameters were evaluated at the beginning of the treatment and after 3 sessions of treatment. Algometer and sEMG were performed also before and after the 1st and 3rd sessions.

详细描述

OBJECTIVE

To compare the efficacy of dry needling and cold spray stretching treatments using surface electromyography (sEMG) and ultrasound (US) in the treatment of patients with myofascial pain syndrome (MPS) with active trigger point (TrP) in the upper trapezius muscle.

MATERIAL AND METHODS

A prospective randomized single-blind study included 60 patients aged 18-65 years who have MPS with ATP in the upper trapezius muscle. Patients were randomized into two treatment groups as dry needling (DN) and cold spray-stretching. Both treatment groups received 1 treatment per week and totally 3 sessions. Evaluation parameters were pain level assessed by visual analog scale (VAS) and algometer, neck range of motion angles, functional level assessed by neck disability index (NDI). The effects of the treatments on aTP were evaluated by sEMG and US histogram. All parameters were evaluated at the beginning of the treatment and after 3 sessions of treatment. Algometer and sEMG were performed also before and after the 1st and 3rd sessions.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neck and / or back pain for at least 3 months,
  • pain level> 3 in VAS measurement
  • presence of active trigger point in upper trapezius muscle

排除标准

  • cervical radiculopathy
  • history of neck and / or shoulder surgery
  • dry needling treatment in the neck and / or shoulder area in the last 1 month
  • coagulation disorder and / or use of anticoagulant therapy
  • migraine or dementia
  • pacemaker
  • needle phobia
  • allergies to the substances in the coolant spray to be used

结局指标

主要结局

pain intensity1

时间窗: Change from baseline at 3rd week

Visual Analog Scale: The Visual Analog Scale (VAS) (0-10 cm) was used to record each patient's current level of neck pain, with 0 indicating no pain and 10 indicating the worst pain that the patient had experienced.Higher scores mean worse outcome

Disability level

时间窗: Change from baseline at 3rd week

Neck Pain Disability Scale: The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100. Higher scores mean worse outcome.

pain intensity2

时间窗: Change from baseline at 3rd week

Algometer: The pain threshold was measured before and after the the first and third sessions with a pressure algometer (Electronic Algometer Commander-USA) in kg / cm². The applied pressure was increased until the point the patient first felt the pain. Measurements were repeated 3 times and the mean average score was recorded.

cervical range of motion angles

时间窗: Change from baseline at 3rd week

measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine

次要结局

  • Surface electromyography(Change from baseline at 3rd week)
  • Gray Scale Ultrasonography(Change from baseline at 3rd week)

研究者

发起方
Haydarpasa Numune Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Geler Külcü

Prof

Haydarpasa Numune Training and Research Hospital

研究点 (1)

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