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

Official title

Clinical Research on Fire Needling Combined With Filiform Needling for Chronic Migraine With Comorbid Tension-type Headache

Overview

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

Detailed description

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.

Interventions

• Procedure 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-
• Procedure 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 week

Primary outcome measures

• Treatment efficacy [Time frame: At week 8 of treatment, and follow-up at week 24 of enrollment]

Secondary outcome measures (11)

• 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) [Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Hamilton Depression Rating Scale, 24-item (HAMD-24) [Time frame: Baseline, at week 8 of treatment, and 24 weeks after enrollment follow-up.]
• Hamilton Anxiety Rating Scale, 14-item [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 [Time frame: Baseline, at week 8 of treatment]
• Pericranial muscle tender area tenderness threshold [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 [Time frame: During the 8-week treatment period]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 3 centers

• Beijing Hospital of Traditional Chinese Medicine — Beijing
• Beijing Tiantan Hospital, Capital Medical University — Beijing
• Capital Medical University Affiliated Beijing Tongren Hospital — Beijing

Identifiers

NCT: NCT07633522 · 2026BL02-023-01 · 2026-2-2233

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗