Acupoint Stimulation Improves Postoperative Wound Pain

NCT06978335 | Enrolling By Invitation

• 1 other identifier: (1090)113A-20
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain remains one of the most common and distressing symptoms experienced by surgical patients. Poorly managed postoperative pain can impede recovery, reduce patient willingness to mobilize, increase the risk of complications, and negatively affect overall quality of life. Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the primary pharmacological strategies for managing postoperative pain. However, these medications often carry the risk of adverse effects and may not adequately address all aspects of patient comfort and recovery. In response to this challenge, this study aims to evaluate the effects of a non-pharmacological, non-invasive intervention-acupoint stimulation-on postoperative wound pain and mobilization in patients undergoing abdominal surgery. Ultimately, this study seeks to contribute to the development of more diversified and patient-centered pain management strategies, with the expectation that the integration of Chinese and Western medicine will lead to improved patient care and enhanced postoperative recovery.

Conditions

Abdominal Surgeries; Pain; Acupuncture Points

Keywords

acupoint stimulation; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measured by Visual Analog Scale (VAS)

  Pain intensity will be assessed using the Visual Analog Scale (VAS). The primary analysis will focus on changes in pain intensity over time between the two groups.

  At 1, 4, 12, 24, 48, and 72 hours post-surgery

Secondary Outcomes (1)

• Pain Impact Assessed by Brief Pain Inventory - Taiwan Version (BPI-Taiwan)

  On postoperative Day 3

Other Outcomes (2)

• Total Analgesic Consumption Within 72 Hours After Surgery

  Within 72 hours after surgery

• Time to First Ambulation After Surgery

  Within 72 hours after surgery

Study Arms (2)

Experimental: Acupoint Stimulation

EXPERIMENTAL

Acupoint stimulation was administered on six points and auricular points on three points on the left ear, additional auricular points were selected according to the abdominal organ involved in surgery and its corresponding meridian representation on the auricle.

Other: Acupoint Stimulation

Control: Sham Acupoint Stimulation

SHAM COMPARATOR

Other: Sham Acupoint Stimulation

Interventions

Acupoint Stimulation OTHER

This intervention involves acupoint stimulation and auricular acupressure. Stimulation of selected body acupoints is administered by trained personnel following a standardized protocol. The intervention is provided once daily for three consecutive days, beginning post-surgery. For auricular acupressure, additional auricular points are chosen based on the involved abdominal organ and its corresponding viscera-meridian locations on the auricle. Vaccaria seeds are applied to the selected points with adhesive patches, and patients are instructed to apply pressure to the points regularly throughout the day.

Experimental: Acupoint Stimulation

Sham Acupoint Stimulation OTHER

Participants in this group will receive a sham acupoint stimulation procedure. Acupoint stimulation will be using identical procedures to the experimental group, without applying pressure. No stimulation or manipulation was performed. The frequency and timing of the sham intervention matched that of the experimental group.

Control: Sham Acupoint Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Surgical wound length ≥ 10 cm
• American Society of Anesthesiologists (ASA) physical status classification I to III
• Receiving intravenous patient-controlled analgesia (IV PCA)
• Clear consciousness and ability to communicate
• Willingness to participate and provide informed consent

You may not qualify if:

• Presence of arrhythmia
• Implanted artificial cardiac pacemaker
• Cutaneous lesions at the acupoint or auricular application sites
• History of chronic pain or abdominal surgery within the past 6 months
• Non-ambulatory status prior to surgery

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Peitou Dist, 112, Taiwan

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: June 19, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)