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

• ClinicalTrials.gov Identifier: NCT04919525
• Recruitment Status: Completed
• First Posted: June 9, 2021
• Last Update Posted: June 16, 2022
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Laura Tabacof, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Device: TrainPain	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Retention rates [ Time Frame: 5 weeks ]
   Retention rates to assess the feasibility of at-home somatosensorial training technology for people with fibromyalgia
2. Adherence rates [ Time Frame: 5 weeks ]
   Adherence rates to the assess feasibility of at-home somatosensorial training technology for people with fibromyalgia
3. 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.
4. 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. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Laura Tabacof, MD; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Laura Tabacof, Postdoctoral Fellow, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT04919525
• Other Study ID Numbers: IRB-20-01292
• First Posted: June 9, 2021
• Last Update Posted: June 16, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laura Tabacof, Icahn School of Medicine at Mount Sinai:

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

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases