Flexible Attention Sensory Training for Youth with Chronic Pain

NCT ID: NCT06051305

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-01-17

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.

Conditions

Persistent Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sensory Training

Daily protocol - gamified sensory training

Group Type: EXPERIMENTAL

Sensory Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Laura E Simons

Professor of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Simons, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Pediatric Pain Clinic

Menlo Park, California, United States

Countries

United States

References

Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 35232455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16051509 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34636750 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 12583873 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18824301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23133619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11132119 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27518484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30496433 (View on PubMed)

Other Identifiers

67616

Identifier Type: -

Identifier Source: org_study_id