Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-2-2233 | Other Grant/Funding Number | Capital's Funds for Health Improvement and Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Capital's Funds for Health Improvement and Research | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingwen Dong | Contact | +8613241104543 | a13241104543@163.com | |
| Hui Lin Liu | Contact | +8613681395789 | liuhuilin@bjzhongyi.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Hui Lin Liu | Beijing Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital of Traditional Chinese Medicine | Beijing | Beijing Municipality | 100010 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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) | 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) | 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 | 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 | By palpation | 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. | Baseline, at week 8 of treatment |
| The status of painkiller intake among subjects | 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. | During the 8-week treatment period |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
|
| Capital Medical University Affiliated Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
|
| ID | Term |
|---|---|
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided