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Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache

4 giugno 2026 aggiornato da: Huilin Liu, Beijing Hospital of Traditional Chinese Medicine

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:

  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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

88

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100070
        • Beijing Tiantan Hospital, Capital Medical University
        • Contatto:
          • baokai Wang
          • Numero di telefono: 86+010+59976611
          • Email: wbk04@126.com
        • Investigatore principale:
          • baokai Wang
      • Beijing, Beijing Municipality, Cina, 100010
        • Beijing Hospital of Traditional Chinese Medicine
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Hui Lin Liu
      • Beijing, Beijing Municipality, Cina, 100730
        • Capital Medical University Affiliated Beijing Tongren Hospital
        • Contatto:
        • Contatto:
          • luquan Chen
        • Investigatore principale:
          • luquan Chen

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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).
Sperimentale: 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.
Procedura: fire needling combined with filiform needling
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment efficacy
Lasso di tempo: 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.
At week 8 of treatment, and follow-up at week 24 of enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Headache days
Lasso di tempo: Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Baseline, at week 8 of treatment, and follow-up at week 24 of enrollment.
Headache Duration
Lasso di tempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Headache severity
Lasso di tempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The proportion of monthly headache attacks occurring ≤1 time per month
Lasso di tempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Migraine-Specific Quality of Life Questionnaire(MSQ) (Version 2.1)
Lasso di tempo: 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.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Depression Rating Scale, 24-item (HAMD-24)
Lasso di tempo: 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.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Hamilton Anxiety Rating Scale, 14-item
Lasso di tempo: 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.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
The number of tender areas in pericranial muscles and their distribution
Lasso di tempo: Baseline, at week 8 of treatment
By palpation
Baseline, at week 8 of treatment
Pericranial muscle tender area tenderness threshold
Lasso di tempo: 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.
Baseline, at week 8 of treatment
The status of painkiller intake among subjects
Lasso di tempo: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.
Recording of adverse events
Lasso di tempo: During the 8-week treatment period
Document adverse events such as needle syncope, hematoma, etc. during acupuncture, along with their grading and management measures.
During the 8-week treatment period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Hospital of Traditional Chinese Medicine

Collaboratori

Capital's Funds for Health Improvement and Research

Investigatori

  • Investigatore principale: Liu Hui Lin Liu, Beijing Hospital of Traditional Chinese Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026BL02-023-01
  • 2026-2-2233 (Altro numero di sovvenzione/finanziamento: Capital's Funds for Health Improvement and Research)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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