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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensory Training | Experimental | Daily protocol - gamified sensory training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory Training | Behavioral | 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. |
| 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) |
| 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) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Simons, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Pediatric Pain Clinic | Menlo Park | California | 94025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260. | ||
| 35232455 | Background | 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. | |
| 16051509 |
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| 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) |
| Baseline, discharge (at 8 weeks) |
| Background |
| 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. |
| 34636750 | Background | 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. |
| Background | 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. |
| 12583873 | Background | 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. |
| 18824301 | Background | 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. |
| 23133619 | Background | 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. |
| 11132119 | Background | 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. |
| 27518484 | Background | 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. |
| 30496433 | Background | 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. |