Trial · NCT07891585
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 | Change From Baseline in Monthly Migraine Days (MMD) at Week 12 | Baseline and Week 12 after treatment initiation | Monthly migraine days (MMD) will be calculated from daily headache diaries over a 28-day period. Change from baseline will be calculated as MMD at Week 12 minus baseline MMD. Negative values indicate a reduction in migraine frequency. The unit of measurement is days per 28 days. |
| Secondary | Change in Monthly Headache Days (MHD) From Baseline to Week 12 | Baseline and monthly through Month 12 | Monthly headache days (MHD) will be calculated from daily headache diaries as the number of days with headache during a 28-day period. Change from baseline will be calculated as the Week 12 value minus the baseline value. Negative values indicate fewer headache days. The unit of measurement is days per 28 days. |
| Secondary | Change in Acute Medication Days (AMD) From Baseline to Week 12 | Baseline and monthly through Month 12 | Acute medication days (AMD) will be defined as the number of days on which participants use acute medication for headache or migraine during a 28-day period, as recorded in daily headache diaries. Change from baseline will be calculated as the Week 12 value minus the baseline value. Negative values indicate reduced acute medication use. The unit of measurement is days per 28 days. |
| Secondary | Change in Headache Pain Intensity From Baseline to Week 12 | Baseline and monthly through Month 12 | Headache pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater headache intensity. Change from baseline will be calculated as the Week 12 score minus the baseline score. Negative values indicate improvement. |
| Secondary | Change in Headache Duration From Baseline to Week 12 | Baseline and monthly through Month 12 | Headache duration will be recorded in daily headache diaries and expressed as the average duration of headache episodes in hours. Change from baseline will be calculated as the Week 12 value minus the baseline value. Negative values indicate shorter headache duration. |
| Secondary | Change in Migraine Disability Assessment (MIDAS) From Baseline to Week 12 | Baseline and monthly through Month 12 | Migraine-related disability will be assessed using the Migraine Disability Assessment (MIDAS). The total score is calculated by summing the number of days of missed or reduced activities across five items during the preceding three months. Higher scores indicate greater migraine-related disability. |
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) From Baseline to Week 12 | Baseline and monthly through Month 12 | Emotional distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale comprises 14 items divided into anxiety and depression subscales, each ranging from 0 to 21. The total score ranges from 0 to 42, with higher scores indicating greater emotional distress. |
| Secondary | Change in Beck Depression Inventory (BDI) From Baseline to Week 12 | Baseline and monthly through Month 12 | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Total Score From Baseline to Week 12 | Baseline and monthly through Month 12 | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score is calculated by summing seven component scores, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be calculated as the Week 12 score minus the baseline score. Negative values indicate improvement. |
| Secondary | Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days at Week 12 | Baseline and monthly through Month 12 | A migraine responder will be defined as a participant achieving at least a 50% reduction in monthly migraine days (MMD) at Week 12 compared with baseline. The outcome will be reported as the percentage of participants meeting this criterion in each treatment group. Higher percentages indicate a greater proportion of treatment responders. |
| Secondary | Change in Regional Brain Volume Assessed by Structural MRI | Baseline, Month 3, and Month 6 | Structural magnetic resonance imaging (MRI) will be used to assess longitudinal changes in regional brain volume following laser acupuncture treatment. Brain volume will be measured in cubic millimeters (mm³). Changes will be evaluated from baseline to Months 3 and 6. Higher or lower values do not necessarily indicate better or worse clinical outcomes. |
| Secondary | Change in Resting-State Functional Connectivity Assessed by fMRI | Baseline, Month 3, and Month 6 | Resting-state functional magnetic resonance imaging (fMRI) will be used to assess longitudinal changes in brain functional connectivity following laser acupuncture treatment. Functional connectivity will be quantified using Fisher's z-transformed correlation coefficients. Changes will be evaluated from baseline to Months 3 and 6. Higher or lower values indicate differences in functional connectivity and do not necessarily represent better or worse clinical outcomes. |
| Secondary | Change in Brain Activation During Laser Acupuncture Assessed by fMRI | Baseline, Month 3, and Month 6 | Task-based functional magnetic resonance imaging (fMRI) will be used to evaluate brain activation responses during laser acupuncture stimulation. Brain activation will be quantified using blood oxygen level-dependent (BOLD) signal changes, expressed as percentage signal change relative to a reference condition. Longitudinal changes will be evaluated from baseline to Months 3 and 6. Higher or lower values do not necessarily indicate better or worse clinical outcomes. |
| Secondary | Change in White Matter Integrity Assessed by Diffusion Tensor Imaging | Baseline, Month 3, and Month 6 | Diffusion tensor imaging (DTI) will be used to assess longitudinal changes in white matter microstructure following laser acupuncture treatment. White matter integrity will be evaluated using fractional anisotropy (FA), a unitless measure ranging from 0 to 1. Changes will be evaluated from baseline to Months 3 and 6. Higher FA values reflect greater directional organization of water diffusion and do not necessarily indicate better clinical outcomes. |
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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