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临床试验/NCT06345430
NCT06345430已完成不适用

Clinical and Functional Effects of Wearable Technological Device Applied to Patients with Chronic Pain

Hacettepe University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2023年12月18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
40
试验地点
2
主要终点
Pain Severity

研究概览

简要总结

Within the scope of this research, a single session of Wearable Technological Device (Exopulse Molli-Suit) will be applied to patients with chronic back and neck pain. The results will be evaluated acutely, after 24 hours, after 1 week and after 1 month.

详细描述

After initial evaluations, patients received a single session for 1 hour. Exopulse Mollii Suit will be applied. The stimulation level of the electrodes will be determined by the automatically by the system in accordance with the level of pain they indicate for their parts, individually tailored to the person.

will be created. Patients will wear the Exopulse Mollii Suit, which is suitable for their body size, Hacettepe University Physics They will dress in the room allocated for them at the Faculty of Treatment and Rehabilitation. After each use The hygiene of Exopulse Mollii Suits has been evaluated at Hacettepe University Faculty of Physical Therapy and Rehabilitation in this will be provided with the help of a special device included in the scope. Initial assessments will be made immediately will be repeated three more times: after the intervention, 24 hours after the intervention and 4 weeks after the intervention.

All data will be collected face-to-face from patients using the instruments mentioned above.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 20-65
  • Pain intensity should be at least 5 according to a numeric scale (low back pain and neck pain)
  • no pain for at least 6 months (healthy people)

排除标准

  • Malignant condition,
  • People with systemic diseases such as neurological, psychological, cardiovascular, rheumatologic diseases and loss of function due to these diseases,
  • History of previous surgery on the spine and upper extremities, including the cervical and lumbar region,
  • Fractures in the spine and upper extremities, including the cervical and lumbar region, with a history of inflammation,
  • Acute infection,
  • Attending another rehabilitation program,
  • Refused to participate in the study and did not give written informed consent

结局指标

主要结局

Pain Severity

时间窗: bBefore the intervention, immediately after the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 5 times

Numeric Pain Scale will be used. On a 10 cm horizontal straight line (0: no pain, 10: most severe pain), the patient will be asked to mark the relevant place according to the severity of the pain. Using a ruler, the distance between point 0 and the marked place will be measured to determine the intensity of the pain.

次要结局

  • back performance test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Disability Level(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Sustained Overhead Work Test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Sleep Qaulity(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Body Composition Analysis(before intervention, 1 times)
  • Lifting object overhead test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)
  • Repetitive Reach Test(Before the intervention, after 24 hours, after 1 week and up to 1 month after the intervention. 4 times)

研究者

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

Ozlem Ulger

Professor

Hacettepe University

研究点 (2)

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