Flexible Attention Sensory Training for Youth With Chronic Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility and acceptability of gamified sensory rehabilitation training technology for children with chronic musculoskeletal pain.

Detailed Description
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The TrainPain devices allows patients with chronic pain to perform sensory rehabilitation training at home, in a gamified format. The system uses a temporary tactile discrimination task, which directly engages inhibitory functions of the somatosensory cortex. In this way, the game trains the brain's sensory system to be more precise. The technology's dual-probe system allows sensory stimuli to be delivered to multiple body locations, which trains patients to flexibly shift their attention towards and away from pain according to dynamic game-directed goals. The sensory training reduces hypervigilance towards painful body regions and enables flexible attention shifting to engage with daily goals. Last, the TrainPain system captures and quantifies performance over time, providing a breadth of intricate and precise data, thus allowing the research team to assess outcomes and mechanisms of training effects. In preliminary studies with adults, TrainPain is shown to be highly engaging, and effective at reducing pain in adults with widespread musculoskeletal (MSK) pain. The current pilot study intends to establish, for the first time, the feasibility and acceptability of using the TrainPain system among youth with chronic MSK pain.

Official Title
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Flexible Attention Sensory Training for Youth With Chronic Pain: A Feasibility and Acceptability Study

Conditions
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Persistent Pain

Intervention / Treatment
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* Behavioral: Sensory Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of musculoskeletal pain including chronic regional pain syndrome English speaking Exclusion Criteria: Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay Severe affect disorders (e.g. severe depression/anxiety) from medical record review Chronic skin disease or topical allergies that would be worsened by the use of sensor tape

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensory Training<br>Daily protocol - gamified sensory training | Behavioral: Sensory Training<br>* Participants will use gamified sensory training technology once daily for 8 weeks. This will involve participants completing a 15 minute sensory training session using the provided technology. The tool used in this study has two components. The first is a game that can be downloaded onto any smartphone device. The second component is two tactile devices that can be attached to the body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Intervention- Net Promoter Score | Acceptability will be evaluated by examining mean promoter score (measured on 10-point Likert scale) post intervention. Range 0-10 (higher scores indicate more acceptability). Questionnaire will be administered to youth with chronic pain. | Discharge (at 8 weeks) | 
| Acceptability of the Intervention- Qualitative Interview | Acceptability will also be assessed qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Survey responses will be reported categorically. Qualitative responses will be described and summarized. | Discharge (at 8 weeks) | 
| Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire | Acceptability will also be assessed quantitatively at the end of treatment through a brief survey related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Survey responses will be reported categorically. Responses are measured using a five-point Likert scale from 'Strongly disagree' to 'Strongly agree' with higher scores indicating greater acceptability. | Discharge (at 8 weeks) | 
| Feasibility of the Intervention- Usage Metrics | Engagement will be assessed via collected use metrics (e.g. how long the app was played each day). | Baseline through discharge (at 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory Short Form (BPI) | The Brief Pain Inventory evaluates the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Measured on a 10-point Likert scale (range 0-10), higher scores indicate greater pain interference. Questionnaire will be administered to youth with chronic pain. | Baseline through discharge (at 8 weeks) weekly and follow up (1-month) | 
| Pediatric PainSCAN | Screening tool for Nerve Pain and Complex Regional Pain Syndrome (CRPS) for children and teens. PainSCAN is a tool used for screening of type of chronic pain condition, and results will be used to gauge pain type and severity. | Baseline, discharge (at 8 weeks), and follow up (1-month) | 
| Bodily Threat Monitoring Scale (BTMS) | Bodily threat monitoring will be assessed via a 19-item self-report measure. Higher scores indicate greater propensity to monitor the body for threatening signs and symptoms. | Baseline, discharge (at 8 weeks), and follow up (1-month) | 
| Patient Global Impression of Change (PGIC) Scale | Single question asking participants to rate how their condition has changed since a specified point in time, with lower scores indicating greater degree of improvement. | Baseline, discharge (at 8 weeks), and follow up (1-month) | 
| Pain Vigilance and Awareness Questionnaire (PVAQ) | The PVAQ is a 16-item measure of attention to pain. Participants are asked to consider behavior over the past 2-weeks and indicate how frequently (0, never; 5, always) an item was true. Higher scores indicate higher pain vigilance and awareness. | Baseline, discharge (at 8 weeks), and follow up (1-month) | 
| Child Pain Acceptance Questionnaire (CPAQ) | Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form will be used to assess pain acceptance in the child. The CPAQ is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items). Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16. Higher scores indicate greater Activity Engagement and greater Pain Willingness. | Baseline, discharge (at 8 weeks), and follow up (1-month) | 
| Multidimensional Assessment of Interoceptive Awareness Youth (MAIA-Y) | The MAIA-Y is an 8-scale state-trait questionnaire with 32 items. It measures multiple dimensions of interoception. Scoring is at the individual scale-level, with higher scores equated with more bodily sensation awareness. The individual score is also given as a percentile relative to normative sample, with extreme percentiles (>10, 90<) of clinical significance. Three scales from this measures are being administered: Attention Regulation, Self-Regulation, Trusting. | Baseline, discharge (at 8 weeks), and follow up (1-month) |