Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache
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:
- Can fire needling significantly reduce the number of headache days per month?
- 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:
- 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
- Keep a headache diary (recording headache frequency, pain intensity, duration, associated symptoms, etc.)
- Regularly complete assessments of emotional status, quality of life, and number of pericranial tender points
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jingwen Dong
- Número de teléfono: +8613241104543
- Correo electrónico: a13241104543@163.com
Copia de seguridad de contactos de estudio
- Nombre: Hui Lin Liu
- Número de teléfono: +8613681395789
- Correo electrónico: liuhuilin@bjzhongyi.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Contacto:
- baokai Wang
- Número de teléfono: 86+010+59976611
- Correo electrónico: wbk04@126.com
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Investigador principal:
- baokai Wang
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Beijing, Beijing Municipality, Porcelana, 100010
- Beijing Hospital of Traditional Chinese Medicine
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Contacto:
- Dong Jingwen Dong
- Número de teléfono: +8613241104543
- Correo electrónico: a13241104543@163.com
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Contacto:
- Hui Lin Liu
- Número de teléfono: 13681395789
- Correo electrónico: liuhuilin@bjzhongyi.com
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Investigador principal:
- Hui Lin Liu
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Beijing, Beijing Municipality, Porcelana, 100730
- Capital Medical University Affiliated Beijing Tongren Hospital
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Contacto:
- luquan Chen
- Número de teléfono: 86+13611373920
- Correo electrónico: chenluquan@ccmu.edu
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Contacto:
- luquan Chen
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Investigador principal:
- luquan Chen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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. |
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). |
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Experimental: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Treatment efficacy
Periodo de tiempo: At week 8 of treatment, and follow-up at week 24 of enrollment
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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.
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At week 8 of treatment, and follow-up at week 24 of enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Headache days
Periodo de tiempo: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
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Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
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Headache Duration
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Headache severity
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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The proportion of monthly headache attacks occurring ≤1 time per month
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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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.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Hamilton Depression Rating Scale, 24-item (HAMD-24)
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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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.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Hamilton Anxiety Rating Scale, 14-item
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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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.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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The number of tender areas in pericranial muscles and their distribution
Periodo de tiempo: Baseline, at week 8 of treatment
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By palpation
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Baseline, at week 8 of treatment
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Pericranial muscle tender area tenderness threshold
Periodo de tiempo: Baseline, at week 8 of treatment
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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.
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Baseline, at week 8 of treatment
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The status of painkiller intake among subjects
Periodo de tiempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
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Recording of adverse events
Periodo de tiempo: During the 8-week treatment period
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Document adverse events such as needle syncope, hematoma, etc. during acupuncture, along with their grading and management measures.
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During the 8-week treatment period
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Liu Hui Lin Liu, Beijing Hospital of Traditional Chinese Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026BL02-023-01
- 2026-2-2233 (Otro número de subvención/financiamiento: Capital's Funds for Health Improvement and Research)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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