Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities (HAPPINESS): Protocol for a Feasibility Study
Notice bibliographique
Résumé
BACKGROUND: Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Medication, as a primary treatment, has insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI, with evidence for effectiveness in reducing pain. Still, there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established. We previously demonstrated feasibility in a pilot study, in which 18 non-Hispanic White adults with SCI completed a 12-week remote Qigong program. However, three additional key elements need to be addressed before performing a larger effectiveness study: (1) feasibility and acceptability of Qigong in adults with SCI with health disparities, (2) feasibility of a study design with a control group, and (3) objective outcome measures. OBJECTIVE: This National Center for Complementary and Integrative Health (NCCIH) R34 feasibility study-the HAPPINESS (Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities) trial-will build upon our prior study to consolidate feasibility with a rigorous protocol. Our aims are (aim 1) to identify facilitators and barriers to participating in a Qigong study through community event meetings, focus groups, and interviews with 40 stakeholders, of whom at least 50% (n=20) have health disparities, and (aim 2) to establish the feasibility of study design and methods through prespecified targets for recruitment and enrollment, feasibility, and acceptability of design and outcomes. METHODS: For aim 1, a total of 40 SCI stakeholders-adults with SCI, caregivers, health care professionals, or other stakeholders who have experience with caring for adults with SCI-will be invited to attend community event meetings, one focus group, or an interview, where they will provide input on facilitators and barriers related to participating in a Qigong study. For aim 2, using a phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain (with at least 50% [n=20] having health disparities) will be randomized to a 12-week remotely delivered Qigong intervention (practicing at least 3×/week with the Spring Forest Qigong's "Five Element Qigong Healing Movements" video), or a short daily pain management survey, completed on a smartphone, iPad, or computer + 6-month follow-up. Feasibility benchmarks, as well as patient-reported outcome measures and objective data from the Fitbit Charge 6 watch, will be collected during the study. RESULTS: The first participant was recruited on August 20, 2024. Study completion is estimated on January 31, 2027. CONCLUSIONS: The study results will facilitate a rigorous structure to design large effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind and body approaches for whole-person health in adults with chronic or neurological disorders, including those with health disparities. TRIAL REGISTRATION: ClinicalTrials.gov NCT06140355; https://clinicaltrials.gov/study/NCT06140355. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/82431.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,086 | 0,060 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,003 |
| Méta-épidémiologie (sens large) | 0,005 | 0,005 |
| Bibliométrie | 0,003 | 0,003 |
| Études des sciences et des technologies | 0,007 | 0,005 |
| Communication savante | 0,004 | 0,004 |
| Science ouverte | 0,004 | 0,004 |
| Intégrité de la recherche | 0,009 | 0,011 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,057 | 0,013 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».