Brief Summary

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.
3.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
4.Keep a headache diary (recording headache frequency, pain intensity, duration, associated symptoms, etc.)
5.Regularly complete assessments of emotional status, quality of life, and number of pericranial tender points

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

28mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach

1 country

3 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

May 18, 2026

Completed

21 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed

2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

May 18, 2026

Last Update Submit

June 4, 2026

Conditions

Tension-type Headache Chronic Migraine

Keywords

fire needlingfiliform needlingchronic migranietension-type headache

Outcome Measures

Primary Outcomes (1)

Treatment efficacy
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

Secondary Outcomes (11)

Headache days
Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Headache Duration
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Headache severity
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The proportion of monthly headache attacks occurring ≤1 time per month
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
+6 more secondary outcomes

Study Arms (2)

filiform needling

ACTIVE COMPARATOR

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.

Procedure: filiform needling

fire needling combined with filiform needling

EXPERIMENTAL

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.

Procedure: fire needling combined with filiform needling

Interventions

filiform needlingPROCEDURE

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).

filiform needling

fire needling combined with filiform needlingPROCEDURE

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.

fire needling combined with filiform needling

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Meets the diagnostic criteria for tension-type headaches with pericranial tenderness;
Meets the diagnostic criteria for chronic migraine;
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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100010, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Capital Medical University Affiliated Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

Liu Hui Lin Liu
Beijing Hospital of Traditional Chinese Medicine
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingwen Dong

CONTACT

+8613241104543 a13241104543@163.com

Hui Lin Liu

CONTACT

+8613681395789 liuhuilin@bjzhongyi.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 8, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing: Will not share

Locations

CN(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

filiform needling

fire needling combined with filiform needling

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations