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

NCT04919525 | Completed

• 1 other identifier: IRB-20-01292
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Gamified; Somatosensory; Temporal discrimination; Cognitive training; Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Retention rates

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

  5 weeks

• Adherence rates

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

  5 weeks

• The System Usability Score

  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

  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

  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 Outcomes (4)

• 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

• Pain Catastrophizing Scale (PCS)

  Baseline and 5 weeks

• Change in Fibromyalgia Assessment Scale (FAS)

  Baseline and 5 weeks

Study Arms (1)

TrainPain Intervention

EXPERIMENTAL

Daily TrainPain protocol - gamified sensory perceptual training

Device: TrainPain

Interventions

TrainPain DEVICE

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.

TrainPain Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Tabacof, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: June 9, 2021
• Study Start: March 18, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)