Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP

NCT06584409 | Recruiting

• 1 other identifier: CF24162B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
2. 2.Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
3. 3.Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
4. 4.Depression, evaluate by Beck's Depression Inventory
5. 5.Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
6. 6.Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
7. 7.Aura of headache
8. 8.Episodic or chronic headache (If patient diagnosed as migraine.)
9. 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, CGRP, substance P, beta-endorphin.

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Difference in the number of headache days per month

  12 weeks, 24 weeks, 36 weeks

• Difference in the of headache attacks lasting hours per month

  12 weeks, 24 weeks, 36 weeks

• Difference in the headache pain intensity (NRS)

  12 weeks, 24 weeks, 36 weeks

• Difference in the number of days with acute headache medication intake per month

  12 weeks, 24 weeks, 36 weeks

• Difference in the Migraine Disability Assessment

  12 weeks, 24 weeks, 36 weeks

Study Arms (2)

Laser treatment

EXPERIMENTAL

CM patients with unsatisfactory pharmacological effects receive laser acupuncture for 8 sessions that spanned 4 weeks. Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)

Device: Laser Pen

Sham treatment

SHAM COMPARATOR

CM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output.

Other: Observation

Interventions

Laser Pen DEVICE

Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)

Laser treatment

Observation OTHER

Sham treatment with no laser output, stimulate the same acupoints as laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) After 6 months followed up, the sham group received truely Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3), and followed up for another 3 months.

Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine patient under the diagnosis and classification of headache was evaluated using the ICHD-3 criteria.

You may not qualify if:

• Age under 18 years old
• Pregnancy

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taichang, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Chi-Hsiang Chou, M.D.

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

• Chi Sheng Wang, M.D.

  Taichung Veterans General Hospital

  STUDY DIRECTOR

• Huan Yun Wu, M.D.

  Taichung Veterans General Hospital

  STUDY DIRECTOR

Central Study Contacts

Yuan-Chen Liu, M.D.

CONTACT

886-972199271; jordan810701@gmail.com

Ching-Chun Chung, M.D.

CONTACT

886-988566621; gracechung1015@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants were randomized by computer software (Excel 2016 for Windows) and the randomization process was overseen by the Institutional Review Board at Taichung Veterans General Hospital. All the participants and our collaborative case-manager were blinded to treatment types.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients was divided to sham group or laser acupuncture group. After 1 months treatment, and followed up for 6 months., the sham group received complementary laser acupuncture for 1 months and followed up for another 3 months.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: April 7, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)