Trial · NCT06977932
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | VAS Response Rate | Baseline, the end of the 2-week treatment. | The proportion of patients with a reduction in VAS score of ≥50% from baseline at the end of the 2-week treatment.The VAS measures pain intensity on a scale from 0 to 10, where higher scores indicate worse pain. The unit of measure is "Percentage of participants". |
| Secondary | Changes in Visual Analog Scale (VAS) scores | At baseline, and at the end of weeks 2, 4, and 8. | Changes in VAS scores from baseline at weeks 2, 4, and 8.The VAS scale ranges from 0 to 10. Higher scores indicate more severe pain. The unit of measure is "Units on a scale". |
| Secondary | Total Days of Rescue Medication Use Assessed by Pain Diary | Daily from baseline through the end of week 8. | Patients will record any use of non-study pain relief medications (rescue analgesia) in their daily pain diary. While the specific type and dosage of the medications are documented in the diary for safety and protocol monitoring, this specific outcome measure evaluates the cumulative total number of days a patient required rescue medication during the entire observation period. A lower number indicates less reliance on additional analgesics. The unit of measure is "Days". |
| Secondary | Average Daily Frequency of Pain Episodes Assessed by Pain Diary | Daily from baseline through the end of week 8. | Patients will record the number of spontaneous and triggered paroxysmal pain episodes daily using a 24-hour pain diary. To capture the continuous trajectory of pain over the entire study period, the daily data will be aggregated and reported as weekly averages. The unit of measure is "Episodes per day". |
| Secondary | Average Daily Pain Intensity Assessed by Pain Diary | Daily from baseline through the end of week 8. | Patients will rate their average pain intensity over the past 24 hours daily using a Visual Analog Scale (VAS) within the pain diary. The VAS ranges from 0 to 10, where higher scores indicate more severe pain. To capture the continuous trajectory, the daily scores will be aggregated and reported as weekly averages. The unit of measure is "Units on a scale". |
| Secondary | Highest Daily Pain Intensity Assessed by Pain Diary | Daily from baseline through the end of week 8. | Patients will rate their peak pain intensity over the past 24 hours daily using a Visual Analog Scale (VAS) within the pain diary. The VAS ranges from 0 to 10, where higher scores indicate worse pain. To capture the continuous trajectory, the daily scores will be aggregated and reported as weekly averages. The unit of measure is "Units on a scale". |
| Secondary | Changes in the Patient global impression of change （PGIC） | At the end of weeks 2, 4, and 8. | The Patient Global Impression of Change (PGIC) scale is a patient-reported outcome measure used to dynamically monitor the trajectory of health status. This scale employs a seven-point Likert scale (1=very much worse to 7=very much better) to assess the impact of therapeutic interventions on an individual's functional status. Treatment efficacy is categorized into three levels: ① disease progression (scores 0-3) indicates a worsening of symptoms; ② functional stability (score 4) suggests no significant change in symptoms; and ③ clinical improvement (scores 5-7) represents a marked reduction in symptoms. This subjective assessment tool, through longitudinal comparison with baseline data, provides a direct reflection of the patient's perceived treatment benefit. The unit of measure is "Units on a scale". |
| Secondary | Changes in the Short-Form McGill Pain Questionnaire （SF-MPQ） | At baseline, and at the end of weeks 2, 4, and 8. | The Short-Form McGill Pain Questionnaire (SF-MPQ) innovatively integrates qualitative and quantitative analyses of neuropathic pain. This involves: (1) Pain quality assessment: Utilizing 11 sensory descriptors (e.g., pricking, burning) and 4 affective descriptors (e.g., annoying, fearful), a 0-3 intensity rating system is established, synthesizing a Pain Rating Index (PRI = sensory score + affective score); (2) Pain intensity assessment: Employing a Visual Analog Scale (VAS) and the Present Pain Intensity index (PPI) for supplementary quantification. This scale significantly enhances clinical applicability while maintaining assessment validity, and has become a gold standard for neuropathic pain assessment. The Pain Rating Index (PRI) is calculated from the descriptors. The total PRI score ranges from 0 to 45. Higher total scores indicate worse neuropathic pain. The unit of measure is "Units on a scale". |
| Secondary | Changes in the Brief pain inventory-facial scale （BPI-Facial） | At baseline, and at the end of weeks 2, 4, and 8. | The Brief Pain Inventory-Facial Scale (BPI-Facial) is designed to establish a three-dimensional assessment system: ① Pain intensity dimension (4 items) quantifies the frequency and severity of pain; ② Daily function dimension (7 items) assesses the impact of pain on basic life activities (including specific emotional states); ③ Facial function dimension (7 items) detects the degree of limitation in specific facial activities. Eighteen standardized items, measured from multiple perspectives, can systematically evaluate pain-related physiological, psychological, and social functional changes, providing multidimensional data support for efficacy determination. Each item is rated on a numerical scale from 0 to 10, yielding a total score that ranges from 0 to 180, where higher scores indicate more severe pain and greater functional impairment. The unit of measure is "Units on a scale". |
| Secondary | Changes in The Self-Rating Anxiety Scale (SAS) | At baseline, and at the end of weeks 2, 4, and 8. | In assessing anxiety via the Self-Rating Anxiety Scale (SAS), scoring yields two key metrics: the raw sum score (X) and the derived standard score (Y). The latter is calculated as the integer portion of 1.25X, with truncation applied. Per Chinese norms, a standard score (Y) of 50 serves as the threshold for clinical anxiety, with severity stratified as mild (50-59), moderate (60-69), or severe (≥70). The standard score ranges from 25 to 100. Higher scores represent more severe anxiety. The unit of measure is "Units on a scale". |
| Secondary | Changes in the Self-Rating Depression Scale (SDS) | At baseline, and at the end of weeks 2, 4, and 8. | The Self-Rating Depression Scale (SDS) is a brief, self-rated instrument for assessing depressive symptomatology. The total raw score (X) is derived by summing all item responses, which is then converted to a standard score (Y) by multiplying by 1.25 and truncating to an integer. Based on Chinese normative data, a standard score cutoff of 53 is adopted, with scores of 53-62, 63-72, and ≥73 indicating mild, moderate, and severe depression, respectively. The standard score ranges from 25 to 100. Higher scores reflect more severe depressive symptoms. The unit of measure is "Units on a scale". |
| Other | Plasma Concentration of Serotonin (5-HT) | At baseline, and at the end of weeks 2 | Plasma levels of 5-HT will be quantified using Enzyme-Linked Immunosorbent Assay (ELISA). The unit of measure is ng/mL. |
| Other | Plasma Concentration of Interleukin-6 (IL-6) | At baseline, and at the end of weeks 2. | Plasma levels of IL-6, a key mediator of neuroinflammation, will be quantified using Enzyme-Linked Immunosorbent Assay (ELISA). The unit of measure is pg/mL. |
| Other | Incidence of Treatment-Related Adverse Events (AEs) | Baseline up to Week 8 | Safety will be evaluated by monitoring the incidence of any adverse events during the study. These include acupuncture-related events (e.g., post-needling pain, subcutaneous hematoma), carbamazepine-related side effects (e.g., dizziness, nausea), and clinically significant laboratory abnormalities identified through Liver Function Tests (LFT) and Renal Function Tests (RFT). The outcome reports the total number of participants experiencing at least one adverse event. The unit of measure is "Number of participants". |
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.
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