Short-Term Effects of Acupuncture on Balance, and Quality of Life in Women With Migraine: A Pilot Study

NCT ID: NCT07145242

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-12-31

Brief Summary

The goal of this clinical trial is to learn about the short-term effects of acupuncture on migraine-related pain, postural balance, and quality of life in women with migraine.

The main questions it aims to answer are:

Does acupuncture reduce migraine pain intensity? Does acupuncture improve balance and postural stability in women with migraine? Does acupuncture improve quality of life in women with migraine? This study does not include a comparison group.

Participants will:

Receive six standardized acupuncture sessions over two weeks (three sessions per week).

Complete questionnaires on pain intensity (Visual Analogue Scale, VAS) and quality of life (SF-36).

Undergo stabilometric balance testing before and after the acupuncture program.

Detailed Description

Migraine is a highly prevalent neurological disorder characterized not only by recurrent headache attacks but also by associated symptoms such as dizziness, balance disturbances, and autonomic dysfunction. These vestibular comorbidities contribute to reduced functional capacity, higher risk of falls, and significantly diminished quality of life. Women of reproductive age are disproportionately affected, making this a critical population for targeted interventions. Conventional pharmacological treatments, while effective for some patients, are often associated with limitations including side effects, contraindications during pregnancy, and insufficient relief of vestibular symptoms. This underlines the need for safe, accessible, and integrative therapeutic approaches.

Acupuncture has gained increasing recognition as a complementary therapy for migraine. Previous clinical trials and meta-analyses have demonstrated its effectiveness in reducing headache frequency and intensity, as well as improving patient-reported quality of life. Proposed mechanisms include the modulation of central pain pathways, regulation of limbic and hypothalamic activity, activation of endogenous opioid release, and improvements in autonomic nervous system balance. However, relatively few studies have examined the effects of acupuncture on postural stability and vestibular-related outcomes in migraine populations, leaving a critical gap in the evidence base.

The current pilot clinical trial was designed to investigate the short-term effects of a standardized two-week acupuncture protocol on three domains:

Migraine pain intensity measured using a visual analogue scale (VAS). Postural stability assessed with stabilometric testing under eyes-open and eyes-closed conditions.

Health-related quality of life assessed with the SF-36 questionnaire. The study enrolled adult women with neurologist-confirmed migraine accompanied by dizziness. Eligible participants received six acupuncture sessions over two weeks, targeting acupoints traditionally linked with migraine relief and vestibular regulation (GB7, GB14, GB20, GV20, LI4, LR3, and Yintang). Treatment was delivered by a licensed acupuncturist, with strict adherence to protocol fidelity and safety monitoring.

The study was designed as a pilot randomized trial to evaluate feasibility and generate preliminary effect size estimates for future larger-scale studies. By focusing not only on pain but also on functional balance and quality of life, this trial expands the scope of acupuncture research in migraine and contributes novel data to an underexplored area.

The expected contribution of this trial is twofold: first, to provide early evidence on the multidimensional benefits of acupuncture in migraine with dizziness; and second, to inform the design, sample size calculation, and outcome selection for future randomized controlled trials. Given the non-invasive and low-risk nature of acupuncture, the findings may have particular clinical relevance for patients seeking integrative care approaches, including those with contraindications to pharmacological therapies.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short-Term Acupuncture for Migraine

Participants in this arm received short-term acupuncture treatment specifically targeted for migraine accompanied by dizziness. The intervention consisted of six acupuncture sessions administered over a two-week period by a licensed acupuncturist. Standardized acupoints (GB7, GB14, GB20, GV20, LI4, LR3, Yintang) were used, with sterile disposable needles inserted according to traditional Chinese medicine guidelines. Each session lasted approximately 30 minutes. No comparator group was included, as this was a pilot exploratory trial.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Intervention Description \* § Add details that will distinguish this intervention from other interventions in this or another clinical study.

Interventions

Acupuncture

Intervention Description \* § Add details that will distinguish this intervention from other interventions in this or another clinical study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult women (≥18 years)
• Neurologist-confirmed diagnosis of migraine according to the International Classification of Headache Disorders (ICHD-3)
• Presence of migraine-related symptoms, including recurrent headaches with or without aura
• Ability and willingness to provide written informed consent

Exclusion Criteria

• Pregnancy
• Presence of other significant neurological or vestibular disorders
• Severe comorbidities that could interfere with balance assessment
• Contraindications for acupuncture treatment (e.g., skin infections at needling sites, bleeding disorders)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pain and Rehabilitation Medicine

OTHER

Sponsor Role: collaborator

Laura Zaliene

OTHER

Sponsor Role: lead

Responsible Party

Laura Zaliene

Lecturer, Klaipėda University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laura Zaliene, PhD

Role: PRINCIPAL_INVESTIGATOR

Klaipėda University

Locations

Klaipeda university

Klaipėda, Klaipėda County, Lithuania

Countries

Lithuania

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Approval No. 6 Sv-HMR-07

Identifier Type: -

Identifier Source: org_study_id