MigraineSAMBANCT07145242
Short-Term Effects of Acupuncture on Balance, and Quality of Life in Women With Migraine: A Pilot Study
A study testing Acupuncture in people with Migraine, run by Laura Zaliene at 1 site in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the 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
- Being tested
- Acupuncture
- Keywords
- acupuncture, migraine, medicine, balance, quality of life, pain mgmt, stress
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Intervention Description * § Add details that will distinguish this intervention from other interventions in this or another clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Short-Term Acupuncture for Migraine | Experimental | 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and at 2 weeks (end of intervention).
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Day 1) and at 2 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jul 2024
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Zaliene
- Sponsor type
- University, hospital or other
- Collaborators
- Pain and Rehabilitation Medicine
- Responsible party
- Sponsor-investigator, Laura Zaliene, Klaipėda University
- Investigators
- Laura Zaliene, PhD, Principal investigator, Klaipėda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145242
- Sponsor's protocol ID
- Approval No. 6 Sv-HMR-07
- Acronym
- SAMBA
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Acupuncture on Balance, and Quality of Life in Women With Migraine: A Pilot Study
- ClinicalTrials.gov ID
- NCT07145242
- Acronym / sponsor ID
- SAMBA / Approval No. 6 Sv-HMR-07
- Conditions
- Migraine
- Keywords
- acupuncture, migraine, medicine, balance, quality of life, pain mgmt, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laura ZalieneUniversity, hospital or other
- Collaborators
- Pain and Rehabilitation Medicine
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-Term Acupuncture for Migraine | Experimental | Other: AcupunctureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureIntervention Description * § Add details that will distinguish this intervention from other interventions in this or another clinical study. | Other | Short-Term Acupuncture for Migraine |
Primary outcome
Change in migraine pain intensity measured by Visual Analogue Scale (VAS)
Time frame: Baseline (Day 1) and at 2 weeks (end of intervention).
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.
2 secondary outcomes
Change in quality of life measured by SF-36
Time frame: Baseline (Day 1) and at 2 weeks (end of intervention)
Change in postural balance measured by stabilometric platform
Time frame: Baseline (Day 1) and at 2 weeks (end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Zaliene, PhD principal investigator
Klaipėda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Migraine, run by Laura Zaliene at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in migraine pain intensity measured by Visual Analogue Scale (VAS) (time frame: Baseline (Day 1) and at 2 weeks (end of intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.