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

June 14, 2022 updated by: Laura Tabacof, Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TrainPain Intervention
Daily TrainPain protocol - gamified sensory perceptual training
Device: TrainPain
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rates
Time Frame: 5 weeks
Retention rates to assess the feasibility of at-home somatosensorial training technology for people with fibromyalgia
5 weeks
Adherence rates
Time Frame: 5 weeks
Adherence rates to the assess feasibility of at-home somatosensorial training technology for people with fibromyalgia
5 weeks
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.
5 weeks
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.
5 weeks
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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 5 weeks
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.
Baseline and 5 weeks
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.
Baseline and 5 weeks
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.
Baseline and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2021

Primary Completion (ACTUAL)

June 3, 2022

Study Completion (ACTUAL)

June 3, 2022

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (ACTUAL)

June 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20-01292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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