Electroacupuncture Versus Thread-Embedding Acupuncture for Knee Osteoarthritis

Summary

This randomized, assessor-blinded, parallel-group controlled trial will compare the effectiveness and safety of thread-embedding acupuncture versus electroacupuncture in patients with primary knee osteoarthritis. Eligible participants will be adults aged 38 years or older diagnosed with primary knee osteoarthritis according to the 1986 American College of Rheumatology criteria, with chronic knee pain lasting more than 6 months and baseline pain intensity of at least 5 points on the Visual Analog Scale.

A total of 60 participants will be randomly assigned in a 1:1 ratio to receive either thread-embedding acupuncture or electroacupuncture. Both groups will receive the same background standard care, including lifestyle advice and therapeutic ultrasound. The intervention period will last 4 weeks. The primary outcome will be change in total Western Ontario and McMaster Universities Osteoarthritis Index score. Secondary outcomes will include pain intensity measured by the Visual Analog Scale, WOMAC subscale scores, Patient Global Impression of Change, treatment satisfaction, rescue analgesic use, and adverse events.

Conditions

• Knee Osteoarthritis (OA)

Interventions

PROCEDURE

Thread-Embedding Acupuncture

Thread-embedding acupuncture will be performed using absorbable catgut thread size 3/0. A 22G injection needle and a 0.30 × 25 mm guide acupuncture needle will be used. Thread length will be approximately 5 to 10 mm. The acupuncture points will include ST35, EX-LE4, GB34, SP9, SP10, and ST34. ST35 and EX-LE4 will be inserted perpendicularly to a depth of approximately 0.5 to 1 cun. GB34, SP9, SP10, and ST34 will be inserted obliquely to a depth of approximately 1 to 2 cun, adjusted according to participant body habitus. The procedure will be performed by a licensed traditional medicine physician with thread-embedding certification and at least 3 years of clinical experience. Participants will be monitored for 30 minutes after each procedure.

PROCEDURE

Electroacupuncture

Electroacupuncture will be performed using sterile, single-use acupuncture needles sized 0.30 × 25 mm. Needles will be inserted perpendicularly or obliquely depending on the acupuncture point and participant body habitus. Deqi sensation will be elicited by manual needle rotation until the participant reports soreness, heaviness, distension, or numbness. The acupuncture points will include ST35, EX-LE4, GB34, SP9, SP10, and ST34. Electrical stimulation will be applied using three electrode pairs: SP10 positive and GB34 negative; ST34 positive and SP9 negative; ST35 positive and EX-LE4 negative. Stimulation parameters will include continuous wave, frequency 60 Hz, pulse width 0.6 ms, and intensity adjusted to participant tolerance. Each session will last 20 minutes using the KWD-808-I electroacupuncture device.

Sponsors & Collaborators

• Dong Nai Traditional Medicine Hospital

  collaborator UNKNOWN

• University of Medicine and Pharmacy at Ho Chi Minh City

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

38 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-03-30

Completion

2026-05-30

Countries

• Vietnam

Study Locations