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临床试验/NCT03840473
NCT03840473已完成不适用

Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Patients With Upper Trapezius Myofascial Trigger Points

King Saud University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Neck pain intensity

研究概览

简要总结

Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle tenderness in the working population is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in patients with upper trapezius Myofascial Trigger points.

详细描述

Purpose: Myofascial pain syndrome, thought to be the main cause of neck pain and shoulder muscle tenderness in the working population, is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in male patients with upper trapezius active MTrPs.

Methods: This was a pretest-posttest single-blinded randomized controlled trial. Sixty male subjects with mechanical neck pain due to upper trapezius active MTrPs were recruited and randomly allocated into group A, which received muscle energy technique (MET) and ischemic compression technique (ICT)along with conventional intervention; group B, which received all the interventions of group A except ICT; and group C, which received conventional treatment only. Baseline (Pr), immediate post-intervention (Po), and 2-week follow-up (Fo) measurements were made for all variables. Pain intensity and pressure pain threshold (PPT)were assessed by a visual analog scale (VAS) and pressure threshold meter, respectively. All three groups received their defined intervention plans only. Repeated-measures analysis of variance was used to perform intra- inter-group analyses. Cohen's d test was used to assess the effect size of the applied interventions within the groups.

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
19 Years 至 38 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male subject diagnosed with non-specific neck pain and muscle tenderness over the upper trapezius muscle due to an active MTrP
  • Age19-38 years
  • Presence of a maximum of 1-2active MTrPs in a unilateral upper trapezius muscle The number of TrPs in upper trapezius is not limited to two; it may be one or may be more than two (satellite TrPs) also. However, due to time constraints of the study sessions allowed for treatment of up to 2 active MTrPs only.

排除标准

  • Diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria;
  • Had active MTrPs in the bilateral upper trapezius muscles
  • Had a history of whiplash injury or cervical spine surgery
  • Were diagnosed with cervical radiculopathy or myelopathy determined by their primary health care physician
  • Had accepted myofascial pain therapy within the 1 month before the study
  • Showed poor cooperation.

研究组 & 干预措施

MET+ICT+Conventional intervention

Experimental

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

干预措施: MET (Behavioral)

MET+Conventional Intervention

Experimental

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

干预措施: MET (Behavioral)

MET+ICT+Conventional intervention

Experimental

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

干预措施: ICT (Behavioral)

MET+ICT+Conventional intervention

Experimental

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

干预措施: Conventional Intervention (Behavioral)

MET+Conventional Intervention

Experimental

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

干预措施: Conventional Intervention (Behavioral)

Conventional Intervention

Active Comparator

Received hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only.

干预措施: Conventional Intervention (Behavioral)

结局指标

主要结局

Neck pain intensity

时间窗: Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up

Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.

Muscle tenderness

时间窗: Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up

A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying "there"/ "yes." Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.

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

AMIR IQBAL

Principle Investigator

King Saud University

研究点 (2)

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