Clinical trial NCT06051305: Flexible Attention Sensory Training for Youth with Chronic Pain
Official title: Flexible Attention Sensory Training for Youth with Chronic Pain: a Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the Intervention- Net Promoter Score
timeFrame: Discharge (at 8 weeks)
measure: Acceptability of the Intervention- Qualitative Interview
timeFrame: Discharge (at 8 weeks)
measure: Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire
timeFrame: Discharge (at 8 weeks)
measure: Feasibility of the Intervention- Usage Metrics
timeFrame: Baseline through discharge (at 8 weeks)
Secondary outcomes:
measure: Brief Pain Inventory Short Form (BPI)
timeFrame: Baseline through discharge (at 8 weeks) weekly and follow up (1-month)
measure: Bodily Threat Monitoring Scale (BTMS)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Patient Global Impression of Change (PGIC) Scale
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Pain Vigilance and Awareness Questionnaire (PVAQ)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Child Pain Acceptance Questionnaire (CPAQ)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Multidimensional Assessment of Interoceptive Awareness Youth (MAIA-Y)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Revised Life Orientation Test (LOT-R)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Childrens Hope Scale (CHS)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Pain Catastrophizing Scale (PCS-C)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Weekly Diary
timeFrame: Treatment (weekly for 8 weeks)
measure: Parent Psychological Flexibility Questionnaire (PPF-P)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
measure: Pain Catastrophizing Scale (PCS-P)
timeFrame: Baseline, discharge (at 8 weeks), and follow up (1-month)
Other outcomes:
measure: Adverse events
timeFrame: Baseline through 8 weeks
measure: Treatment Expectancy and Credibility (TEC)
timeFrame: Baseline, discharge (at 8 weeks)
Locations:
city: Menlo Park
country: United States
facility: Stanford Pediatric Pain Clinic
state: California
Study officials:
affiliation: Stanford University
name: Laura Simons, PhD
role: PRINCIPAL_INVESTIGATOR
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