Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities (HAPPINESS): Protocol for a Feasibility Study
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.086 | 0.060 |
| Meta-epidemiology (narrow) | 0.004 | 0.003 |
| Meta-epidemiology (broad) | 0.005 | 0.005 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.007 | 0.005 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.004 |
| Research integrity | 0.009 | 0.011 |
| Insufficient payload (model declined to judge) | 0.057 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".