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Persistent PainNCT06051305

Flexible Attention Sensory Training for Youth with Chronic Pain

A study testing Sensory Training in people with Persistent Pain, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Persistent Pain
What is being tested?
Sensory Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
16 Oct 2023to 17 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of musculoskeletal pain including chronic regional pain syndrome
  • English speaking

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Pediatric Pain Clinic

    Menlo Park, California, 94025

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Sensory Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory TrainingBehavioural

    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.

Study groups in NCT06051305
Study groupRoleWhat they receive
Sensory TrainingExperimentalDaily protocol - gamified sensory training
Receives: Behavioral: Sensory Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Discharge (at 8 weeks)

  2. 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.

    Measured: Discharge (at 8 weeks)

  3. 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.

    Measured: Discharge (at 8 weeks)

  4. Feasibility of the Intervention- Usage Metrics

    Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).

    Measured: Baseline through discharge (at 8 weeks)

Secondary outcomes (12)

  1. 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.

    Measured: Baseline through discharge (at 8 weeks) weekly and follow up (1-month)

  2. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  3. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  4. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  5. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  6. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  7. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  8. 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/

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  9. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  10. 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.

    Measured: Treatment (weekly for 8 weeks)

  11. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

  12. 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.

    Measured: Baseline, discharge (at 8 weeks), and follow up (1-month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start16 Oct 2023
  3. Primary completion9 Jan 2025
  4. Study completion17 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06051305
Sponsor's protocol ID
67616
Status last verified
Feb 2025
First submitted
16 Aug 2023
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 35232455

  • 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.

    PubMed 16051509

  • 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.

    PubMed 34636750

  • 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.

    PubMed 12583873

  • 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.

    PubMed 18824301

  • 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.

    PubMed 23133619

  • 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.

    PubMed 11132119

  • 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.

    PubMed 27518484

  • 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.

    PubMed 30496433

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Training in people with Persistent Pain, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the Intervention- Net Promoter Score (time frame: Discharge (at 8 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06051305, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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