Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
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|ClinicalTrials.gov Identifier: NCT04919525|
Recruitment Status : Completed
First Posted : June 9, 2021
Last Update Posted : June 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: TrainPain||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial|
|Actual Study Start Date :||March 18, 2021|
|Actual Primary Completion Date :||June 3, 2022|
|Actual Study Completion Date :||June 3, 2022|
Experimental: TrainPain Intervention
Daily TrainPain protocol - gamified sensory perceptual training
Participants will use gamified sensory perceptual training technology once daily for 28 days. This will involve participants completing a 15 minute sensory training session using the provided technology and viewing a 5 minute web based pain management lesson; additionally, participants will receive daily text messages. The device used in this study has two components. The first is a video game that can be downloaded onto any smartphone device. The second component is two vibrational devices that can be attached to the arms, legs, upper back, and lower back.
- Retention rates [ Time Frame: 5 weeks ]Retention rates to assess the feasibility of at-home somatosensorial training technology for people with fibromyalgia
- Adherence rates [ Time Frame: 5 weeks ]Adherence rates to the assess feasibility of at-home somatosensorial training technology for people with fibromyalgia
- The System Usability Score [ Time Frame: 5 weeks ]Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
- The Net Promoter Score [ Time Frame: 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 [ Time Frame: 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.
- Change The Pain, Enjoyment of Life and General Activity (PEG) Scale [ Time Frame: Baseline and 5 weeks ]The Pain, Enjoyment of Life and General Activity (PEG) Scale consists of 3 separate numerical scales. Each scale has ratings ranging from 0-10. The PEG scale is scored by averaging the three numbers. Full scale from 0-10, higher score indicates worse pain, and pain interference. Change in score at 5 weeks compared to baseline.
- Change Patient Global Impression of Change (PGIC) [ Time Frame: Baseline and 5 weeks ]The Patient's Global Impression of Change (PGIC) Full score from -3 to 3, with higher score indicating more improvement. Change in score at 5 weeks compared to baseline.
- Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline and 5 weeks ]The PCS contains 13 questions. The full score ranges from 0 to 39 where a higher score correlates with more extreme pain catastrophization.
- Change in Fibromyalgia Assessment Scale (FAS) [ Time Frame: Baseline and 5 weeks ]Fibromyalgia Assessment Scale (FAS) is a short and easy to complete self-administered index combining a set of questions relating to non-articular pain (SAPS range 0 to 10), fatigue (range 0 to 10), and the quality of sleep (range 0 to 10) that provides a single composite measure of disease activity ranging from 0 to 10. higher score indicates poorer health outcomes. Change in score at 5 weeks compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919525
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Laura Tabacof, MD||Icahn School of Medicine at Mount Sinai|