Short-Term Effects of Acupuncture on Balance, and Quality of Life in Women With Migraine: A Pilot Study
Phase: NA
Conditions: Migraine
Sponsor: Laura Zaliene

Study Protocol and Statistical Analysis Plan 
Study Protocol 
Title: 
Short-Term Effects of Acupuncture on Balance and Quality of Life in Women with Migraine: A Pilot 
Study 
ClinicalTrials.gov Identifier (NCT Number): 
Responsible Party: 
Klaipėda University, Holistic Medicine and Rehabilitation Department 
Principal Investigator: 
PhD Laura Zaliene, Klaipėda University 
Document Date: 
2025-08-25 
2. Background and Rationale 
Migraine is a common neurological condition frequently accompanied by dizziness and 
impaired balance, which negatively affects quality of life. Pharmacological treatments often 
provide insufficient relief or are associated with side effects. Acupuncture has shown 
promise as a complementary therapy, but evidence regarding its short-term effects on 
balance and quality of life remains limited. 
3. Objectives 
Primary Objective: To evaluate the short-term effects of acupuncture on balance and quality 
of life in women with migraine. 
4. Study Design 
This is a single-arm, prospective pilot study without a control group. All participants 
received acupuncture treatment over a defined intervention period. 
5. Participants 
Inclusion Criteria: Female, ≥18 years, clinical diagnosis of migraine with dizziness, 
willingness to participate and comply with the protocol. 
Exclusion Criteria: Severe comorbidities, contraindications to acupuncture, pregnancy, or 
refusal to provide informed consent. 
6. Intervention 
Participants underwent a short-cycle acupuncture intervention targeting standardized 
acupoints associated with migraine management (e.g., GB7, GB14, GB20, GV20, LI4, LR3, 
Yintang). Treatment was administered twice weekly for 3 weeks, resulting in a total of 6 
sessions. Each session lasted approximately 30 minutes. 
7. Outcomes 
Primary Outcomes: Migraine intensity (VAS), postural stability (stabilometric parameters), 
and quality of life (SF-36). 
Secondary Outcomes: Dizziness symptoms, participant-reported well-being. 
8. Data Collection and Timeline 
Baseline data were collected prior to the intervention. Post-intervention data were collected 
immediately after the last acupuncture session. All outcome measures were assessed at both 
time points. 
9. Statistical Analysis 
Descriptive statistics (mean±SD, frequencies) will be used to summarize participant 
characteristics and outcomes. Paired-sample t-tests or non-parametric equivalents will be 
applied to assess pre–post intervention changes. Effect sizes (Cohen’s d) will be calculated. 
Missing data will be handled using available case analysis. 

10. Ethics 
The study protocol was approved by the Klaipėda University Bioethics Committee. All 
participants provided written informed consent before participation. The study adhered to 
the principles of the Declaration of Helsinki. 
11. Dissemination 
Findings will be disseminated through peer-reviewed publications and conference 
presentations. Results are intended to inform future randomized controlled trials.