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Flexible Attention Sensory Training for Youth With Chronic Pain

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ClinicalTrials.gov Identifier: NCT06051305
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Laura E Simons, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Persistent Pain Behavioral: Sensory Training Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flexible Attention Sensory Training for Youth With Chronic Pain: A Feasibility and Acceptability Study
Actual Study Start Date : October 16, 2023
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sensory Training
Daily protocol - gamified sensory training
 Behavioral: Sensory Training
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.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability of the Intervention- Net Promoter Score [ Time Frame: Discharge (at 8 weeks) ]
    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.

  2. Acceptability of the Intervention- Qualitative Interview [ Time Frame: Discharge (at 8 weeks) ]
    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.

  3. Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire [ Time Frame: Discharge (at 8 weeks) ]
    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.

  4. Feasibility of the Intervention- Usage Metrics [ Time Frame: Baseline through discharge (at 8 weeks) ]
    Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).


Secondary Outcome Measures :
  1. Brief Pain Inventory Short Form (BPI) [ Time Frame: Baseline through discharge (at 8 weeks) weekly and follow up (1-month) ]
    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.

  2. Pediatric PainSCAN [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]
    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.

  3. Bodily Threat Monitoring Scale (BTMS) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]
    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.

  4. Patient Global Impression of Change (PGIC) Scale [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]
    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.

  5. Pain Vigilance and Awareness Questionnaire (PVAQ) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]
    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.

  6. Child Pain Acceptance Questionnaire (CPAQ) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]
    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.

  7. Multidimensional Assessment of Interoceptive Awareness Youth (MAIA-Y) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]
    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.


Other Outcome Measures:
  1. Adverse events [ Time Frame: Baseline through 8 weeks ]
  2. Treatment Expectancy and Credibility (TEC) [ Time Frame: Baseline, discharge (at 8 weeks) ]
    Participants (child) and parent expectations for treatment will be measured by the Treatment Expectancy and Creditability. The TEC is comprised of 6 items rated on a 0 to 10 Likert-scale assessing expectations related to the effectiveness of the current treatment. The TEC is completed by the patient at the end of the first treatment session and at the end of treatment (8 weeks). Higher scores indicate greater expectations for treatment effectiveness.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051305


Contacts
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Contact: Laura Simons, PhD (650) 723-6412 lesimons@stanford.edu
Contact: Nicole Jehl, BS (650) 725-8111 njehl@stanford.edu

Locations
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United States, California
Stanford Pediatric Pain Clinic Recruiting
Menlo Park, California, United States, 94025
Contact: Nicole Jehl, B.S.    650-725-8111    njehl@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Laura Simons, PhD Stanford University
More Information
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Publications:
Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
Ferguson, L., & Scheman, J. (2009). Patient global impression of change scores within the context of a chronic pain rehabilitation program. The Journal of Pain, 10(4), S73.

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Responsible Party: Laura E Simons, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT06051305    
Other Study ID Numbers: 67616
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations