跳至主要内容
临床试验/NCT06229925
NCT06229925招募中不适用

Effects of Transcranial Direct Current Stimulation Versus Sham in Subacromial Pain Syndrome: A Randomized Controlled Trial

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
2
主要终点
Pain intensity (numerical pain rating scale)

研究概览

简要总结

The purpose of this study is to investigate the effects of applying Transcranial direct current stimulation on pain levels and function, quality of life, muscle strength and range of motion in individuals with subacromial pain syndrome.

详细描述

This is a controlled, randomized and blind clinical trial, which will be carried out with individuals from the city of Natal/RN, aged between 18 and 65 years, of both sexes, diagnosed with subacromial pain syndrome, who present a level of pain greater than 3 on the Numerical Pain Scale, at rest, for at least 3 months. The research sample will be non-probabilistic, in which they will be randomly distributed into two distinct groups: active tDCS (active stimulation) and sham tDCS (stimulation turned off after 20 seconds). This research was submitted to the UFRN Research Ethics Committee through the national interface Plataforma Brasil. This research covers the ethical aspects guided by Resolution 466/2012 of the National Health Council and the Declaration of Helsinki for research with human beings. In addition, the research will be registered in Clinical Trials. All data will be recorded in the laboratory's database under confidentiality and may only be processed by the responsible researchers. The study will only begin after the issuance of the reference opinion approving the project. All subjects will be duly informed and guided regarding the scheduled procedures, which will only be carried out after reading, accepting and signing the Informed Consent Form. After approval by the Research Ethics Committee, following resolution 466/2012, a pilot study was carried out to adapt all research procedures, as well as training the researchers involved. Volunteers will be duly informed about the objectives and advantages of their participation in the study, and will then undergo an assessment of pain sensation, using the Numerical Pain Scale; assessment of shoulder range of motion, using the Smartphone clinometer application; assessment of muscle strength through flexion, hyperextension, medial and lateral rotation movements of the shoulder, using a portable dynamometer; will complete the Douleur Neuropathique 4 questionnaire (DN4) to screen for neuropathic pain, the Disabilities of the arm, shoulder and hand questionnaire (DASH) to assess upper limb function, and the Short Form 36 Health Survey questionnaire (SF-36) to assess health-related quality of life. They will then undergo 20 minutes of stimulation for 5 consecutive days, according to the pre-determined group. The assessments will be repeated at the end of the intervention and in a 1-week follow-up, in which they will receive an educational booklet.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral pain in one shoulder
  • Pain level ≥ 3 on the Numerical Pain Scale (END), at rest, for at least 3 months
  • No previous treatment with tDCS
  • Present graded disability on the DASH questionnaire (> 15 points)
  • At least three positive tests, among the five indicated below: Neer, Hawkins, Jobe, Patte or painful abduction arch.

排除标准

  • Indication for surgical repair and/or history of shoulder surgery
  • Shoulder fracture and/or dislocation
  • Partial or total rupture of one of the rotator cuff tendons and/or the long head of the biceps
  • Fibromyalgia
  • History of epilepsy
  • Panic syndrome
  • Implantable devices in the skull
  • Significant neurological or psychiatric diseases
  • Severe cardiopulmonary, renal and hepatic diseases
  • Current pregnancy.

结局指标

主要结局

Pain intensity (numerical pain rating scale)

时间窗: Up to 1 week of follow-up

Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.

次要结局

  • Range of motion (ROM)(Up to 1 week of follow-up)
  • Degree of disability of the upper limbs(Up to 1 week of follow-up)
  • Health-related Quality of Life(Up to 1 week of follow-up)
  • Peak of muscular torque(Up to 1 week of follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamilson Simões Brasileiro

Professor and Researcher

Universidade Federal do Rio Grande do Norte

研究点 (2)

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