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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Other: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Klaipėda County
    • Klaipėda, Klaipėda County, Lithuania
      • Klaipeda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in migraine pain intensity measured by Visual Analogue Scale (VAS)	Migraine pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." The primary outcome is the change in mean VAS score from baseline to 2 weeks post-intervention.	Baseline (Day 1) and at 2 weeks (end of intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life measured by SF-36	Quality of life will be assessed using the validated SF-36 Questionnaire, which evaluates the impact of migraine on daily functioning across role function, emotional function, and social domains. The secondary outcome is defined as the change in total MSQ score from baseline to 2 weeks post-intervention.	Baseline (Day 1) and at 2 weeks (end of intervention)
Change in postural balance measured by stabilometric platform	Postural balance will be evaluated using a stabilometric platform by measuring center-of-pressure (COP) displacement in quiet standing. The outcome is defined as the change in mean sway path length and sway area from baseline to 2 weeks post-intervention.	Baseline (Day 1) and at 2 weeks (end of intervention)

Collaborators and Investigators

• Sponsor: Laura Zaliene
• Collaborators: Pain and Rehabilitation Medicine
• Investigators: Principal Investigator: Laura Zaliene, PhD, Klaipeda University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Estimated): August 28, 2025

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: acupuncture, migraine, medicine, balance, quality of life, pain mgmt, stress
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: Approval No. 6 Sv-HMR-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of health-related information. Ensuring participant privacy and compliance with ethical regulations precludes the public sharing of individual-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No