Effect Of Electroacupuncture With Local Anesthesia On Pain And Stress During Impacted Lower Third Molar Surgery (EASE)

Effect Of Electroacupuncture As An Adjunct To Local Anesthesia On Perioperative Pain And Stress During Ambulatory Surgical Extraction Of Impacted Lower Third Molars

This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Stress, Psychological; Impacted Lower Third Molar
• Intervention / Treatment: Procedure: Electroacupuncture; Procedure: Sham Acupuncture

Detailed Description

Perioperative pain and stress during surgical extraction of impacted lower third molars remain clinically relevant despite the use of local anesthesia. Psychological factors such as dental anxiety and physiological stress responses contribute to variability in pain perception and perioperative outcomes. Electroacupuncture has been proposed as a non-pharmacological adjunct that may modulate both nociceptive and stress-related pathways through neurohumoral mechanisms, including endogenous opioid release and autonomic regulation.

This prospective randomized controlled trial is designed to evaluate the effect of electroacupuncture as an adjunct to local anesthesia on perioperative response in patients undergoing ambulatory surgical extraction of impacted lower third molars. The study incorporates a three-arm parallel design, including electroacupuncture, sham acupuncture, and standard care without acupuncture, allowing differentiation between specific and non-specific effects of the intervention.

An integrated assessment approach will be used to capture multiple dimensions of the perioperative response, including subjective, biological, and physiological components. This design enables a comprehensive evaluation of the interaction between stress, autonomic activation, and nociceptive processing in a standardized oral surgery model. The findings are expected to contribute to the understanding of the clinical value of electroacupuncture as an adjunctive modality in perioperative care.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Salaric, Associate Professor, PhD; Phone Number: 003851290 2444; Email: salaric@sfzg.unizg.hr
• Study Contact Backup: Name: Monika Ilić, MD; Email: monika.seric.ilic@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Dubrava
    • Contact: Ivan Salaric; Phone Number: 003851 2902 444; Email: salaric@sfzg.unizg.hr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged 25-35 years
• ASA physical status I-II
• Indication for ambulatory surgical extraction of an impacted lower third molar
• Ability to understand the study procedures and provide written informed consent
• Willingness to comply with study procedures, including saliva sampling protocol
• Ability to abstain from food, beverages, and oral hygiene procedures for at least 1 hour prior to saliva sampling

Exclusion Criteria:

• Pregnancy
• Epilepsy
• Presence of a pacemaker or other active electronic implant
• Coagulation disorders
• Active infection at the site of acupuncture
• Systemic inflammatory diseases
• Oral inflammatory conditions (e.g., gingivitis or periodontitis)
• Hyposalivation
• Chronic opioid use
• Psychiatric conditions that may affect pain or stress assessment
• Use of nonsteroidal anti-inflammatory drugs, corticosteroids, or antibiotics within 7 days prior to the procedure
• Menstruation at the time of saliva sampling
• Inability or unwillingness to comply with study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture Group; Participants receive electroacupuncture for 15 minutes prior to administration of local anesthesia, according to a standardized protocol involving selected local and distal acupuncture points. Electrical stimulation is applied using a digital electroacupuncture device at an individually adjusted intensity sufficient to produce a clear sensation without pain or discomfort. Following the intervention, participants undergo standard surgical extraction of the impacted lower third molar under local anesthesia.	Procedure: Electroacupuncture; Electroacupuncture is applied for 15 minutes prior to local anesthesia using a standardized protocol with selected acupuncture points. Electrical stimulation is delivered via a digital electroacupuncture device at an individually adjusted intensity to produce a clear but non-painful sensation.
Sham Comparator: Sham Acupuncture Group; Participants receive a sham acupuncture procedure for 15 minutes prior to administration of local anesthesia. This involves superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation, mimicking the procedural aspects of electroacupuncture without therapeutic effect. The duration and conditions are identical to the electroacupuncture group. After the procedure, participants undergo standard surgical extraction under local anesthesia.	Procedure: Sham Acupuncture; Sham acupuncture consists of superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation. The procedure mimics the active intervention in duration and setting but is designed to have no therapeutic effect.
No Intervention: Control Group; Participants receive standard care consisting of local anesthesia and surgical extraction of the impacted lower third molar without any acupuncture intervention. All other aspects of perioperative management are consistent with routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Pain Intensity	Perioperative pain intensity assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores represent a worse outcome.	Baseline and 30 minutes after surgical extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	Perceived stress assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no stress and 10 indicates the highest perceived stress, and the 10-item Perceived Stress Scale (PSS-10); higher scores on both scales indicate greater perceived stress and a worse outcome.	Baseline and 30 minutes after surgical extraction
Salivary Cortisol Levels	Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA).	Baseline and 30 minutes after surgical extraction
Salivary Alpha-Amylase Levels	Salivary alpha-amylase concentrations measured as an indicator of sympathetic activity using enzyme-linked immunosorbent assay (ELISA).	Baseline and 30 minutes after surgical extraction
Salivary Substance P Levels	Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response.	Baseline and 30 minutes after surgical extraction
Systolic Blood Pressure	Systolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg).	Baseline and immediately after surgical extraction
Diastolic Blood Pressure	Diastolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg).	Baseline and immediately after surgical extraction
Heart Rate	Heart rate measured using a validated automated digital monitor as an indicator of autonomic response, reported in beats per minute (bpm).	Baseline and immediately after surgical extraction

Collaborators and Investigators

• Sponsor: University of Zagreb
• Investigators: Study Chair: Jasminka Peršec, Associate Professor, PhD, University Hospital Dubrava

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): December 18, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cortisol; Substance P; Electroacupuncture; Dental Anxiety; Alpha-Amylase; Third Molar Surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain, Postoperative; Stress, Psychological; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: 003-01/26-05/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy considerations and the absence of a predefined data-sharing plan within this investigator-initiated study. Data will be reported in aggregate form in scientific publications.

Drug and device information, study documents

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