Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP: A Single Blind RCT.
NCT Number: NCT06584409
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Headache, Migraine
Interventions: DEVICE: Laser Pen|OTHER: Observation
Sponsor: Taichung Veterans General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-10-01

Summary:
Aims:

To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.

Methods:

In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep.

In addition, patients' characteristics will be investigated as follows:

1. Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
2. Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
3. Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
4. Depression, evaluate by Beck's Depression Inventory
5. Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
6. Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
7. Aura of headache
8. Episodic or chronic headache (If patient diagnosed as migraine.)
9. Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2 and CGRP.

Importance:

In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2 and CGRP for approval. Look forward to help improve therapeutic strategies in clinical practice.

Primary Outcome Measures: cGRP, change in cGRP from baasline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|MMP2, change in MMP2 from baasline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks
Secondary Outcome Measures: Difference in the number of headache days per month, change in monthly migraine days (MMD) from baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|Difference in the of headache attacks lasting hours per month, change in acute headache medications usage days per month from baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|Difference in the headache pain intensity (NRS), changes in the headache severity (based on NRS) between baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|Difference in the number of days with acute headache medication intake per month, change in acute headache medications usage days per month from baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|Difference in the MIDAS, changes in the MIDAS score between baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|Difference in the BDI (Beck's Depression Inventory), change in BDI score between baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|Difference in the HADS(Hospital Anxiety and Depression Scale), change in HADS score between baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks|30% reduction in migraine days, ≥ 30% reduction in migraine days between baseline and each follow-up time point, 12 weeks, 24 weeks, 36 weeks