Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
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
- 否
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
Laura Tabacof
Postdoctoral Fellow
Icahn School of Medicine at Mount Sinai
