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临床试验/NCT04475965
NCT04475965已完成不适用

The Influence of the Intensity of Isometric Exercise on Pain Intensity, Muscle Pain Sensitivity and Function in Patients With Chronic Shoulder Pain: A Parallel Single-blind Randomized Study

Jorge Fuentes2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年12月1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
82
试验地点
2
主要终点
Pain intensity Numerical Rating Scale

研究概览

简要总结

The aim of this study was to evaluate the influence of the intensity of Isometric Contraction of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary isometric contraction) on pain intensity, pain thresholds, and function in chronic pain shoulder patients.

详细描述

This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41) received a five-series Isometric Contraction of shoulder external rotators at 20% maximal voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period. Outcome measures included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain intensity numerical rating score), and shoulder function (Constant Score).

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

The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female having a chronic shoulder soft-tissue injury of at least 3 month duration resulting in a mild to moderate level of disability (Constant score scale), pain intensity score between 3 and 8 points (pain intensity numerical rating scale), and age between 18 and 65 years.

排除标准

  • Participants were excluded if they had any contraindications related to the application of isometric exercise, neurological problems (central or peripheral), concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic disease conditions, had participated in any moderate or vigorous physical activity in the las 72 hours previous the outcome assessment.

结局指标

主要结局

Pain intensity Numerical Rating Scale

时间窗: Baseline through the end of the intervention (2 week period)

The Pain intensity Numerical Rating Scale is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a number on a horizontally depicted 11-point scale from 0 (no pain) to 10 (worst possible pain). Based on its several advantages (i.e. more responsive, sensitive and easy to administer) over other pain measuring scales, the PI-NRS has been recommended as a core outcome measure in clinical trials of chronic pain treatments. The minimal clinically important change for this scale has been reported to range from 1.5 to 3.2 points. Other authors have determined a meaningful clinical change of 2 points from baseline pain scores.

次要结局

  • Shoulder function(Baseline through the end of the intervention (2 week period))
  • Muscle pain sensitivity(Baseline through the end of the intervention (2 week period))

研究者

发起方
Jorge Fuentes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jorge Fuentes

Clinical professor

Universidad Católica del Maule

研究点 (2)

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