FibromyalgiaNCT04919525
Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
A study testing TrainPain in people with Fibromyalgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- TrainPain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 3 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 65 at consent
- Chronic pain ( at least 3 months)
- Minimum average pain of 4 in the NRS
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- TrainPain
- Keywords
- Gamified, Somatosensory, Temporal discrimination, Cognitive training, Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainPainDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TrainPain Intervention | Experimental | Daily TrainPain protocol - gamified sensory perceptual training Receives: Device: TrainPain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rates
Retention rates to assess the feasibility of at-home somatosensorial training technology for people with fibromyalgia
Measured: 5 weeks
Adherence rates
Adherence rates to the assess feasibility of at-home somatosensorial training technology for people with fibromyalgia
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 weeks
Secondary outcomes (4)
Change The Pain, Enjoyment of Life and General Activity (PEG) Scale
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.
Measured: Baseline and 5 weeks
Change Patient Global Impression of Change (PGIC)
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.
Measured: Baseline and 5 weeks
Pain Catastrophizing Scale (PCS)
The PCS contains 13 questions. The full score ranges from 0 to 39 where a higher score correlates with more extreme pain catastrophization.
Measured: Baseline and 5 weeks
Change in Fibromyalgia Assessment Scale (FAS)
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.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start18 Mar 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Tabacof, Icahn School of Medicine at Mount Sinai
- Investigators
- Laura Tabacof, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919525
- Sponsor's protocol ID
- IRB-20-01292
- Status last verified
- Jun 2022
- First submitted
- 5 May 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT04919525
- Acronym / sponsor ID
- IRB-20-01292
- Conditions
- Fibromyalgia
- Keywords
- Gamified, Somatosensory, Temporal discrimination, Cognitive training, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TrainPain Intervention | Experimental | Device: TrainPainDaily TrainPain protocol - gamified sensory perceptual training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 18 and 65 at consent
- Chronic pain ( at least 3 months)
- Minimum average pain of 4 in the NRS
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainPainParticipants 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. | Device | TrainPain Intervention |
Primary outcome
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.
4 secondary outcomes
Change The Pain, Enjoyment of Life and General Activity (PEG) Scale
Time frame: Baseline and 5 weeks
Change Patient Global Impression of Change (PGIC)
Time frame: Baseline and 5 weeks
Pain Catastrophizing Scale (PCS)
Time frame: Baseline and 5 weeks
Change in Fibromyalgia Assessment Scale (FAS)
Time frame: Baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Tabacof, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrainPain in people with Fibromyalgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rates (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.