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临床试验/NCT04919525
NCT04919525已完成不适用

Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年3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
11
试验地点
1
主要终点
The System Usability Score

研究概览

简要总结

The purpose of this study is to determine the feasibility of gamified sensory perceptual training in people with fibromyalgia. The primary aim is to determine the feasibility of at-home somatosensorial training for people with fibromyalgia. The researchers are determining the feasibility of using this device to decrease chronic neuropathic pain in people with fibromyalgia. The secondary aim is to survey participants' subjective report of clinical change after this program.

详细描述

Fibromyalgia is a pain syndrome characterized by central sensitization, and hypersensitivity to nociceptive stimuli. In people with fibromyalgia, objective measures of sensory perception are often impaired. For example, somatosensory temporal discrimination thresholds are elevated, and this correlates with increased widespread pain and severity of other symptoms including fatigue, sleep quality, cognitive symptoms, somatic symptoms and decreased functional status. Sensory-Cognitive training may reduce symptoms by improving attentional modulation of somatosensory signals, improving precision of sensory discrimination, and altering affective processing of somatosensation. The objective of this study is to evaluate the feasibility of the TrainPain program as a somatosensory therapy for people with fibromyalgia.. This study plans to enroll 30 participants between the ages of 18 and 65 who are diagnosed with fibromyalgia and have been experiencing chronic pain with an NRS rating of 4/10 for at least 3 months. All participants who agree to participate in this study will answer a set of baseline questionnaires (PEG, FAS) about their symptoms at the time of inclusion. Participants will also receive the device, and view a demonstration of how to use the technology. The technology consists of two components; (1) an application downloaded to the participants' smartphone and (2) two vibrational devices to be placed on the body of the participant, connected to the application via bluetooth. Participants will use this technology once daily for 28 days. Participants will complete a 15 minute sensory training session using the provided technology; additionally, participants will receive daily text messages to promote pain self-management, and program adherence. Participants will also complete the PEG questionnaire once weekly. After 28 days study team members will conduct a virtual follow-up visit. In that visit, participants will complete the same questionnaires as at baseline (PEG, FAS), as well as a question on their perception of clinical change (PGIC). Participants will also be asked to complete the system usability scale and provide a net promoter score. Finally, participants will complete a subjective feedback questionnaire where they will rate whether participating in this program was time well spent and enjoyable. The primary aim is to determine the feasibility of at-home somatosensorial training for people with fibromyalgia. The secondary aim is to survey participants' subjective report of clinical change after this.

研究设计

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

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

  • Ages between 18 and 65 at consent
  • Chronic pain ( at least 3 months)
  • Minimum average pain of 4 in the NRS

排除标准

  • Not able to comprehend English written language
  • Chronic skin disease or topical allergies that would be worsened by the use of sensor tape
  • Severe psychiatric disorder (Patient Health Questionnaire)

结局指标

主要结局

The System Usability Score

时间窗: 5 weeks

Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.

Retention rates

时间窗: 5 weeks

Retention rates to assess the feasibility of at-home somatosensorial training technology for people with fibromyalgia

Adherence rates

时间窗: 5 weeks

Adherence rates to the assess feasibility of at-home somatosensorial training technology for people with fibromyalgia

The Net Promoter Score

时间窗: 5 weeks

The Net Promoter Score is an index ranging from 0-10 that measures the willingness of customers to recommend a company's products or services to others as a measure of opinion on the feasibility on using the device. Higher score indicates higher recommendation.

The Subjective Feedback Questionnaire

时间窗: 5 weeks

The Subjective Feedback Questionnaire asks participants to rate the acceptability, enjoyment, and perceived usefulness (0-10) of the program as a measure of opinion on the feasibility on using the device. Higher score indicates higher enjoyment. There are also 12 subjective yes/no questions asking participants to report their opinions of the program and its affect on their pain and quality of life. Finally, there are two open-ended questions that give participants the opportunity to provide feedback on the program.

次要结局

  • Change The Pain, Enjoyment of Life and General Activity (PEG) Scale(Baseline and 5 weeks)
  • Change Patient Global Impression of Change (PGIC)(Baseline and 5 weeks)
  • Change in Fibromyalgia Assessment Scale (FAS)(Baseline and 5 weeks)
  • Pain Catastrophizing Scale (PCS)(Baseline and 5 weeks)

研究者

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

Laura Tabacof

Postdoctoral Fellow

Icahn School of Medicine at Mount Sinai

研究点 (1)

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