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

2026年6月4日 更新者：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

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

88

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100070
        • Beijing Tiantan Hospital, Capital Medical University
        • 接触：
          • baokai Wang
          • 电话号码：86+010+59976611
          • 邮箱：wbk04@126.com
        • 首席研究员：
          • baokai Wang
      • Beijing、Beijing Municipality、中国、100010
        • Beijing Hospital of Traditional Chinese Medicine
        • 接触：
        • 接触：
        • 首席研究员：
          • Hui Lin Liu
      • Beijing、Beijing Municipality、中国、100730
        • Capital Medical University Affiliated Beijing Tongren Hospital
        • 接触：
        • 接触：
          • luquan Chen
        • 首席研究员：
          • luquan Chen

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
程序：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).
实验性的：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.
程序：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Treatment efficacy
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Headache days
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：Baseline, at week 8 of treatment
By palpation
Baseline, at week 8 of treatment
Pericranial muscle tender area tenderness threshold
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Beijing Hospital of Traditional Chinese Medicine

合作者

Capital's Funds for Health Improvement and Research

调查人员

  • 首席研究员：Liu Hui Lin Liu、Beijing Hospital of Traditional Chinese Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026BL02-023-01
  • 2026-2-2233 (其他赠款/资助编号：Capital's Funds for Health Improvement and Research)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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