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

2026년 6월 4일 업데이트: Huilin Liu, Beijing Hospital of Traditional Chinese Medicine

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

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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

88

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100070
        • Beijing Tiantan Hospital, Capital Medical University
        • 연락하다:
          • baokai Wang
          • 전화번호: 86+010+59976611
          • 이메일: wbk04@126.com
        • 수석 연구원:
          • baokai Wang
      • Beijing, Beijing Municipality, 중국, 100010
        • Beijing Hospital of Traditional Chinese Medicine
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Hui Lin Liu
      • Beijing, Beijing Municipality, 중국, 100730
        • Capital Medical University Affiliated Beijing Tongren Hospital
        • 연락하다:
        • 연락하다:
          • luquan Chen
        • 수석 연구원:
          • luquan Chen

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: filiform needling

This point selection protocol follows the international standard acupuncture preventive treatment regimen specified in the Acupuncture Clinical Practice Guideline: Migraine (WFAS 007.8-2023) issued by the World Federation of Acupuncture-Moxibustion Societies (WFAS).

Main Points Baihui (GV20), Shenting (GV24), Fengchi (GB20, bilateral), Benshen (GB13, bilateral), Shuaigu (GB8, bilateral), Taiyang (EX-HN5, bilateral).

Adjuvant Points For Shaoyang headache: add Toulinqi (GB15), Yangbai (GB14), Fubai (GB10), Zulinqi (GB41), Waiguan (TE5), Yanglingquan (GB34).

For Yangming headache: add Touwei (ST8), Hegu (LI4), Neiting (ST44). For Taiyang headache: add Kunlun (BL60), Houxi (SI3). For Jueyin headache: add Taichong (LR3), Qiuxu (GB40). Procedure Fengchi (GB20) is needled 0.5-1 cun toward the nasal tip. All other points are needled perpendicularly. Following the arrival of de qi, even reinforcing-reducing method is applied, with needles retained for 30 minutes.
절차: 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-HN5, bilateral).

Adjunct Acupoints:

For shaoyang headache: add Toulinqi (GB15), Yangbai (GB14), Fubai (GB10), Zulinqi (GB41), Waiguan (SJ5), Yanglingquan (GB34); For yangming headache: add Touwei (ST8), Hegu (LI4), Neiting (ST44); For taiyang headache: add Kunlun (BL60), Houxi (SI3); For jueyin headache: add Taichong (LR3), Qiuxu (GB40).
실험적: fire needling combined with filiform needling
Fire needle prickling was applied to the pericranial tenderness areas, combined with filiform needle acupuncture at meridian points. The acupoint prescription for filiform needle acupuncture was identical to that in the control group.
절차: 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 weekly for 8 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Treatment efficacy
기간: At week 8 of treatment, and follow-up at week 24 of enrollment
Based on the statistics from the headache diaries completed by patients, it is defined as the proportion of subjects who achieve a reduction in headache days of ≥50% after treatment compared to before treatment.
At week 8 of treatment, and follow-up at week 24 of enrollment

2차 결과 측정

결과 측정
측정값 설명
기간
Headache days
기간: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Headache Duration
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Headache severity
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The proportion of monthly headache attacks occurring ≤1 time per month
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Depression Rating Scale, 24-item (HAMD-24)
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The HAMD-24 is a clinician-administered scale used to assess the severity of depressive symptoms. It consists of 24 items, most of which are scored from 0 to 4 (0 = absent, 4 = very severe), and a few items are scored from 0 to 2 (0 = absent, 2 = marked). The total score ranges from 0 to 76, with higher scores indicating more severe depression.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Anxiety Rating Scale, 14-item
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The HAMA-14 is a clinician-administered scale used to assess the severity of anxiety symptoms. It consists of 14 items, each scored on a 5-point scale from 0 (not present) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The number of tender areas in pericranial muscles and their distribution
기간: Baseline, at week 8 of treatment
By palpation
Baseline, at week 8 of treatment
Pericranial muscle tender area tenderness threshold
기간: Baseline, at week 8 of treatment
The subject is instructed to relax naturally and sit on a chair with a backrest. The researcher uses an electronic pressure meter (SHSCYQ ZMF-50) to perform standardized assessment and recording of the tender points identified through palpation. A 1 cm² circular probe of the device is placed perpendicularly over the palpated tender point and pressed evenly into the skin at a rate of 0.5 N/s. The subject presses a feedback button as soon as pain is felt, and the pressure value displayed at that moment is recorded. Each tender point is measured three times, with an interval of 10 to 15 seconds between measurements. The average of the three values is calculated as the pressure pain threshold for that tender point.
Baseline, at week 8 of treatment
The status of painkiller intake among subjects
기간: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Recording of adverse events
기간: During the 8-week treatment period
Document adverse events such as needle syncope, hematoma, etc. during acupuncture, along with their grading and management measures.
During the 8-week treatment period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Hospital of Traditional Chinese Medicine

협력자

Capital's Funds for Health Improvement and Research

수사관

  • 수석 연구원: Liu Hui Lin Liu, Beijing Hospital of Traditional Chinese Medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026BL02-023-01
  • 2026-2-2233 (기타 보조금/기금 번호: Capital's Funds for Health Improvement and Research)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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