Clinical trial NCT04919525: Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
Official title: Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Gamified
Somatosensory
Temporal discrimination
Cognitive training
Chronic Pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility 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)

Primary outcomes:
measure: Retention rates
timeFrame: 5 weeks
measure: Adherence rates
timeFrame: 5 weeks
measure: The System Usability Score
timeFrame: 5 weeks
measure: The Net Promoter Score
timeFrame: 5 weeks
measure: The Subjective Feedback Questionnaire
timeFrame: 5 weeks
Secondary outcomes:
measure: Change The Pain, Enjoyment of Life and General Activity (PEG) Scale
timeFrame: Baseline and 5 weeks
measure: Change Patient Global Impression of Change (PGIC)
timeFrame: Baseline and 5 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline and 5 weeks
measure: Change in Fibromyalgia Assessment Scale (FAS)
timeFrame: Baseline and 5 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laura Tabacof, MD
role: PRINCIPAL_INVESTIGATOR
References: