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临床试验/NCT04305223
NCT04305223已完成不适用

Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache

Emory University2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Change in visual analog score for pain level

研究概览

简要总结

This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.

详细描述

This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.

The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.

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)

盲法说明

Investigators assessing outcome measures will be blinded to participants' group assignment.

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

  • Unilateral headache (HA) without side shift
  • H/o pain triggered by neck movement
  • Limitation in cervical range of motion
  • Ispilateral neck, shoulder or arm pain
  • Intermittent pain with episodes varying in duration
  • Head and neck pain is non-throbbing in nature

排除标准

  • Use of anti-coagulation medicine (except low dose aspirin)
  • Pregnancy
  • Acute or uncontrolled medical illness
  • Opioid use within six months
  • Fibromyalgia or diffuse painful syndromes in the UE or LE
  • Substance abuse
  • Presence of fever, vomiting or visual changes

结局指标

主要结局

Change in visual analog score for pain level

时间窗: Baseline, Weeks 1 to 4 post intervention

Pain is reported using a Visual Analog Scale from 0-10 and evaluates the frequency, severity and duration of the pain. Higher score indicates worse outcome.

Change in pain pressure threshold (PPT)

时间窗: Baseline, Weeks 1 to 4 post intervention

Pressure algometry is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. Measured with a pressure algometer: 0-50 KPa/s (kilopascal/second squared), minimum score representing increased pain to light touch/measuring allodynia.

Change in Pain Frequency-Severity-Duration (PFDS) Scale

时间窗: Baseline, Weeks 1 to 4 post intervention

PFSD scale ranges from 1-140 with higher scores indicative of higher disability. There is a composite score that ranges from 0-140. Higher score correlates with worse outcome.

Change in cervical range of motion

时间窗: Baseline, Weeks 1 to 4 post intervention

Will measure C1-2 Active Range of Motion, min score, 0; max score 50 degrees, lower score more limited (worse outcome).

Functional outcome measure: Change in neck disability index

时间窗: Baseline, Weeks 1 to 4 post intervention

Score ranges from 0-50 points: higher scores indicate higher levels of disability; Minimal detectable change (MDC), 5 points.

Functional outcome measure: Change in headache disability index

时间窗: Baseline, Weeks 1 to 4 post intervention

Score ranges from 0-72: 0 is no disability, 72 is more severe disability. Minimally Clinically Important Difference (MCID) is 29 points.

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

Kathleen Geist

Associate Professor

Emory University

研究点 (2)

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