Trial · NCT07909473
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intervention Acceptability | At completion of study (6 weeks) | We assessed acceptability using the Theoretical Framework of Acceptability (TFA) Questionnaire. 7 TFA constructs are assessed, along with general acceptability items scores. Total score max = 35, with higher scores indicating higher acceptability of healthcare intervention. |
| Primary | Feasibility of Enrollment | Duration of recruitment period, up to approximately 16 months | we will calculate the proportion of people who were approached for study participation and enrolled |
| Primary | Feasibility of Data Collection/Retention | From enrollment to completion of study at 6 weeks | We will calculate the percentage of participants who completed the surveys at each data collection time point (baseline, 3 weeks, 6 weeks) compared to those that did not. |
| Primary | Intervention Fidelity | Duration of recruitment period, up to approximately 16 months | Reported as the proportion (%) of acupuncture sessions attended (out of 10). |
| Primary | Intervention Acceptability Qualitative Interviews | At completion of study (6 weeks) | Interviews were conducted on a subset of participants and included questions assessing participant experiences with the intervention, perceived effectiveness of the intervention, and overall acceptability of the intervention. All interviews were transcribed verbatim, and the transcripts served as the data source. |
| Secondary | Pain Impact | Baseline, 3 weeks, 6 week data collection timepoints | PEG Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity). Score is calculated by adding the scores of its three questions and dividing the total by three to get an average score from 0 to 10. |
| Secondary | Pain Location | Baseline, 3 weeks, 6 weeks | Pain location (selected on body image); location \& number of pain locations summarized based on participant selection on body map image. |
| Secondary | Neuropathic Pain | Baseline & 6 weeks data collection timepoints | PROMIS Neuropathic Pain Quality. T-score generated, with scores ≥ 50 suggesting a likely or prominent neuropathic pain quality phenotype |
| Secondary | Nociceptive Pain | Baseline and 6-week data collection timepoint | PROMIS Nociceptive Pain questionnaire. T-score generate, with a score \>50 suggesting nociceptive pain involvement. |
| Secondary | Pain Self-Efficacy | Baseline & 6 week data collection timepoint | Pain Self-Efficacy Questionnaire. Scored by adding the numerical ratings of all 10 items, resulting in a total score from 0 to 60. Higher scores indicate greater pain self-efficacy. |
| Secondary | Pain Concerns | Baseline & 6-week data collection timepoint | UW Concerns About Pain 2-item short-form questionnaire. T-score generated, with higher T-score representing higher levels of pain catastrophizing. |
| Secondary | Anxiety | Baseline, 3-week, and 6-week data collection timepoint. | PROMIS Anxiety Short Form (4-item). Scoring using T-score, with higher scores indicating higher levels of symptoms. |
| Secondary | Depressive Symptoms | Baseline, 3-week, and 6-week data collection timepoints | PROMIS Depressive Symptoms Short Form (4-item). Scoring using T-score, with higher scores indicating higher levels/burden of symptoms. |
| Secondary | Sleep Disturbances | Baseline, 3-week, and 6-week data collection timepoint | PROMIS SLeep Disturbances Short-Form (4-item). Scoring using T-score, with higher scores indicating higher severity of sleep disturbance. |
| Secondary | Fatigue | Baseline, 3-week, and 6-week data collection timepoint. | PROMIS Fatigue Short Form (4-item). Scoring using T-score, with higher scores indicating higher levels/burden of fatigue. |
| Secondary | Global Physical Health | Baseline, 3-week, & 6-week data collection timepoints. | PROMIS Global Health - Physical 2-item form. Scoring using T-score, with higher scores indicating better physical health. |
| Secondary | Current Pain Medication Use | Baseline, 3-week, & 6-week data collection timepoint | Assesses if participant is taking medications for pain. If so, questions around the frequency and type of pain medicines an individual is taking. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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