An interventional study of filiform needling and fire needling combined with filiform needling in Chronic Migraine and Tension-type Headache, sponsored by Beijing Hospital of Traditional Chinese Medicine. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Beijing Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
143 studies on the registry are indexed under Tension-Type Headache; 42 are open to participants now.
This study's planned enrollment of 88 is above the median of 60 across 108 interventional studies indexed under Tension-Type Headache.
Browse Tension-Type Headache studies →Beijing Hospital of Traditional Chinese Medicine is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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 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.
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.
Time frame: At week 8 of treatment, and follow-up at week 24 of enrollment
Headache days
Time frame: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Headache Duration
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Headache severity
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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.
Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
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.
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Depression Rating Scale, 24-item (HAMD-24)
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.
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Anxiety Rating Scale, 14-item
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.
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The number of tender areas in pericranial muscles and their distribution
By palpation
Time frame: Baseline, at week 8 of treatment
Pericranial muscle tender area tenderness threshold
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.
Time frame: Baseline, at week 8 of treatment
The status of painkiller intake among subjects
Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Recording of adverse events
Document adverse events such as needle syncope, hematoma, etc. during acupuncture, along with their grading and management measures.
Time frame: During the 8-week treatment period
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2028, 28 months later.
Of 49 non-industry interventional studies with no phase under Tension-Type Headache, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's planned 28 months is above that.
Counting every sponsor, half of 49 studies reached it within 7 months; a quarter within 3 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Beijing Hospital of Traditional Chinese Medicine