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NCT Number: NCT07633522

Fire Needling Plus 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

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Tension-Type Headache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hospital of Traditional Chinese Medicine, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

filiform needling

Procedure

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).

fire needling combined with filiform needling

Procedure

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.

Primary outcomes

  1. Treatment efficacy

    Time frame: 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.

Secondary outcomes

  1. Headache days

    Time frame: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.

  2. Headache Duration

    Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.

  3. Headache severity

    Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.

  4. The proportion of monthly headache attacks occurring ≤1 time per month

    Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.

  5. Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)

    Time frame: 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.

  6. Hamilton Depression Rating Scale, 24-item (HAMD-24)

    Time frame: 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.

  7. Hamilton Anxiety Rating Scale, 14-item

    Time frame: 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.

  8. The number of tender areas in pericranial muscles and their distribution

    Time frame: Baseline, at week 8 of treatment

    By palpation

  9. Pericranial muscle tender area tenderness threshold

    Time frame: 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.

  10. The status of painkiller intake among subjects

    Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.

  11. Recording of adverse events

    Time frame: During the 8-week treatment period

    Document adverse events such as needle syncope, hematoma, etc. during acupuncture, along with their grading and management measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Lin Liu

CONTACT

[email protected]

+8613681395789

Jingwen Dong

CONTACT

[email protected]

+8613241104543

Sponsors and collaborators

Lead sponsor

Beijing Hospital of Traditional Chinese Medicine

Other

Collaborators

  • Capital's Funds for Health Improvement and Research

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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