Flexible Attention Sensory Training for Youth with Chronic Pain

Flexible Attention Sensory Training for Youth with Chronic Pain: a Feasibility and Acceptability Study

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

Study Overview

• Status: Completed
• Conditions: Persistent Pain
• Intervention / Treatment: Behavioral: Sensory Training

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • Stanford Pediatric Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)
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)
Revised Life Orientation Test (LOT-R)	The Revised Life Orientation Test will be used to assess self-reported optimism in the child. The LOT-R is a 10-item measure yielding a total score ranging from 0-20 (only 5 items are utilized in the final score calculation). Higher scores indicate greater optimism.	Baseline, discharge (at 8 weeks), and follow up (1-month)
Childrens Hope Scale (CHS)	The Childrens Hope Scale will be used to assess self-reported hope in the child. The CHS is a 6-item measure yielding a total score ranging from 0-36, with higher scores indicating greater hope/	Baseline, discharge (at 8 weeks), and follow up (1-month)
Pain Catastrophizing Scale (PCS-C)	The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.	Baseline, discharge (at 8 weeks), and follow up (1-month)
Weekly Diary	We are administering an additional 13-item weekly diary, developed by our group, which measure self-reported fear, avoidance, functioning, activity engagement, pain reactivity, and attention.	Treatment (weekly for 8 weeks)
Parent Psychological Flexibility Questionnaire (PPF-P)	The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain. Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40. Higher scores indicate greater parent psychological flexibility.	Baseline, discharge (at 8 weeks), and follow up (1-month)
Pain Catastrophizing Scale (PCS-P)	Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain. It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true"). A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking.	Baseline, discharge (at 8 weeks), and follow up (1-month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		Baseline through 8 weeks
Treatment Expectancy and Credibility (TEC)	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.	Baseline, discharge (at 8 weeks)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Laura Simons, PhD, Stanford University

Publications and helpful links

General Publications

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
• Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.
• Castarlenas E, Jensen MP, von Baeyer CL, Miro J. Psychometric Properties of the Numerical Rating Scale to Assess Self-Reported Pain Intensity in Children and Adolescents: A Systematic Review. Clin J Pain. 2017 Apr;33(4):376-383. doi: 10.1097/AJP.0000000000000406.
• Mendoza T, Mayne T, Rublee D, Cleeland C. Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain. 2006 May;10(4):353-61. doi: 10.1016/j.ejpain.2005.06.002. Epub 2005 Jul 26.
• Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
• Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
• Gauntlett-Gilbert J, Alamire B, Duggan GB. Pain Acceptance in Adolescents: Development of a Short Form of the CPAQ-A. J Pediatr Psychol. 2019 May 1;44(4):453-462. doi: 10.1093/jpepsy/jsy090.
• Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
• Mesaroli G, Campbell F, Hundert A, Birnie KA, Sun N, Davidge KM, Lalloo C, Davies-Chalmers C, Harris L, Stinson J. Development of a Screening Tool for Pediatric Neuropathic Pain and Complex Regional Pain Syndrome: Pediatric PainSCAN. Clin J Pain. 2021 Oct 12;38(1):15-22. doi: 10.1097/AJP.0000000000000993.
• 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.
• Roelofs J, Peters ML, McCracken L, Vlaeyen JWS. The pain vigilance and awareness questionnaire (PVAQ): further psychometric evaluation in fibromyalgia and other chronic pain syndromes. Pain. 2003 Feb;101(3):299-306. doi: 10.1016/S0304-3959(02)00338-X.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): January 9, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 67616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No