Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache

Официальное название

Clinical Research on Fire Needling Combined With Filiform Needling for Chronic Migraine With Comorbid Tension-type Headache

Обзор

The investigators conducted a multicenter, prospective, randomized controlled clinical study to learn whether fire needling combined with filiform needling applied to pericranial muscle tenderness areas can effectively treat chronic migraine with comorbid tension-type headache. The study will also evaluate the safety and long-term efficacy of this therapy. Its main target questions include: 1. Can fire needling significantly reduce the number of headache days per month? 2. What is the effect of this therapy on headache intensity, emotional symptoms, and quality of life? The investigators will compare "fire needling at pericranial tender points plus conventional filiform needling" versus "conventional filiform needling alone" to verify whether the key technique of fire needling plus conventional filiform needling provides unique additive value. Participants will: 1. Receive treatment twice per week for 8 weeks (either in the experimental group or the control group)，attend a follow-up visit at week 24 after enrollment 2. Keep a headache diary (recording headache frequency, pain intensity, duration, associated symptoms, etc.) 3. Regularly complete assessments of emotional status, quality of life, and number of pericranial tender points

Подробное описание

Based on international research progress and our preliminary findings, our team proposes that headache episodes in chronic migraine often present with clinical features of tension-type headache. Patients commonly exhibit widespread pericranial muscle tenderness. Integrating the trigemino-cervical complex (TCC) pathway theory and the long-term foundation of acupuncture treatment for tension-type headache, the investigators propose that chronic migraine primarily develops from the comorbidity of migraine and tension-type headache, with pericranial muscle tenderness being a key pathogenic factor and therapeutic target. Fire-needle pinpointing of tender points in pericranial muscles is a key technique for achieving favorable outcomes.

This multicenter randomized controlled trial will enroll 88 patients with chronic migraine comorbid with tension-type headache. They will be randomly allocated in a 1:1 ratio to either the experimental group or the control group via a central randomization system. The experimental group will receive "fire-needle pinpointing of pericranial tender points plus conventional filiform needle acupuncture," while the control group will receive "conventional filiform needle acupuncture" only. Treatment will be administered twice weekly for 8 weeks, with a follow-up period of 24 weeks.

The study will evaluate clinical efficacy and safety by comparing the two groups in terms of headache days, pain intensity, duration, associated symptoms, emotional status, quality of life, number of pericranial tender points, and safety indicators before and after treatment and at the end of the follow-up period. The aim is to confirm that "pericranial muscle tender areas are the key therapeutic target for chronic migraine comorbid with tension-type headache" and that "fire-needle pinpointing is the key technique for this target." The primary outcome will be the internationally recognized headache frequency. Secondary outcomes will include headache intensity, headache-related emotional symptoms, and health-related quality of life. Long-term follow-up will assess sustained effects, with the goal of providing an acupuncture-based treatment strategy to significantly improve the clinical efficacy for chronic migraine.

Вмешательства

• Процедура filiform needling
  Selection of acupoints for filiform needle therapy is integrated with the international standard acupuncture preventive treatment protocol for migraine specified in Acupuncture Clinical Practice Guidelines for Migraine issued by the World Federation of Acupuncture-Moxibustion Societies （WFAS 007.8-2023）.Treatment was administered twice weekly for 8 weeks. Main Acupoints: Baihui (GV20), Shenting (GV24), Fengchi (GB20, bilateral), Benshen (GB13, bilateral), Shuaigu (GB8, bilateral), Taiyang (EX-
• Процедура fire needling combined with filiform needling
  Fire needling was used to puncture pericranial muscle tenderness areas (including the external occipital protuberance, superior nuchal line, nuchal plane, mastoid process; cervicoscapular areas; epicranial aponeurosis - frontal and temporal regions; upper trapezius, sternocleidomastoid, levator scapulae, temporalis, masseter, and occipitofrontalis muscles) in addition to filiform needling at meridian acupoints (same acupoints as the filiform needling group). Treatment was administered twice week

Первичные конечные точки

• Treatment efficacy [Срок оценки: At week 8 of treatment, and follow-up at week 24 of enrollment]

Вторичные конечные точки (11)

• Headache days [Срок оценки: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.]
• Headache Duration [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Headache severity [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• The proportion of monthly headache attacks occurring ≤1 time per month [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1) [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Hamilton Depression Rating Scale, 24-item (HAMD-24) [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Hamilton Anxiety Rating Scale, 14-item [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• The number of tender areas in pericranial muscles and their distribution [Срок оценки: Baseline, at week 8 of treatment]
• Pericranial muscle tender area tenderness threshold [Срок оценки: Baseline, at week 8 of treatment]
• The status of painkiller intake among subjects [Срок оценки: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Recording of adverse events [Срок оценки: During the 8-week treatment period]

Критерии участия

Критерии включения

• Meets the diagnostic criteria for tension-type headaches with pericranial tenderness;
• Meets the diagnostic criteria for chronic migraine;
• 18 years ≤ age ≤ 65 years;
• Has sufficient understanding to complete the necessary examinations and tests for the study;
• Voluntarily joins this study and signs the informed consent form.

Критерии исключения

• Patients complicated with cluster headache or other primary headaches;
• Patients with secondary headaches caused by intracranial space-occupying lesions, cranial infections, etc.;
• Patients complicated with severe heart, liver or kidney impairment, coagulation disorders, infections, severe immunocompromise, or allergic predisposition;
• Patients with alcohol or drug dependence;
• Patients who are unable to cooperate with acupuncture treatment;
• Women who are planning pregnancy, pregnant or breastfeeding;
• Patients who have received acupuncture treatment within 3 months prior to enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Beijing Hospital of Traditional Chinese Medicine — Пекин
• Beijing Tiantan Hospital, Capital Medical University — Пекин
• Capital Medical University Affiliated Beijing Tongren Hospital — Пекин

Идентификаторы

NCT: NCT07633522 · 2026BL02-023-01 · 2026-2-2233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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