Electroacupuncture Versus Thread-Embedding Acupuncture for Knee Osteoarthritis

NCT07665125 | Completed DMC

• 1 other identifier: 495/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Electroacupuncture; Knee osteoarthritis; Thread-embedding acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in Total WOMAC Score

  The Western Ontario and McMaster Universities Osteoarthritis Index will be used to assess knee osteoarthritis symptoms and function. The total WOMAC score ranges from 0 to 96 points, with higher scores indicating worse pain, stiffness, and functional limitation. The primary endpoint will be the change in total WOMAC score from baseline to Week 4.

  Baseline, Week 2, and Week 4

Secondary Outcomes (1)

• Change in WChange in Knee Pain Intensity on the Visual Analog ScaleOMAC Pain Subscale Score

  Baseline, Week 2, and Week 4

Other Outcomes (2)

• Patient Global Impression of Change

  Week 4

• Treatment Satisfaction Visual Analog Scale

  Week 4

Study Arms (2)

Thread-Embedding Acupuncture

EXPERIMENTAL

Participants assigned to this arm will receive thread-embedding acupuncture once every 2 weeks for 4 weeks, for a total of 2 sessions. Each session will last approximately 10 to 15 minutes. Participants will also receive the same background standard care as the comparator group, including lifestyle modification advice and therapeutic ultrasound.

Procedure: Thread-Embedding Acupuncture

Electroacupuncture

ACTIVE COMPARATOR

Participants assigned to this arm will receive electroacupuncture 5 sessions per week for 4 weeks, excluding Saturdays and Sundays, for a total of 20 sessions. Each session will last 20 minutes. Participants will also receive the same background standard care as the thread-embedding acupuncture group, including lifestyle modification advice and therapeutic ultrasound.

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

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.

Electroacupuncture

Thread-Embedding Acupuncture PROCEDURE

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.

Thread-Embedding Acupuncture

Eligibility Criteria

• Age: 38 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 38 years or older.
• Diagnosis of primary knee osteoarthritis according to the 1986 American - College of Rheumatology criteria.
• Chronic knee pain lasting more than 6 months.
• Baseline knee pain intensity of at least 5 points on the Visual Analog Scale.
• No use of nonsteroidal anti-inflammatory drugs within 1 week before study enrollment.
• Willingness to participate in the study and ability to provide written informed consent.

You may not qualify if:

• Systemic diseases, including rheumatoid arthritis, hematological disorders such as coagulation disorders or platelet dysfunction, severe cardiovascular disease such as heart failure or unstable angina, systemic infection, malignancy, immunodeficiency, or current use of immunosuppressive medication or anticoagulant medication.
• Acute knee arthritis with swelling or knee joint effusion.
• Peripheral platelet count less than 150,000/mm³.
• Pregnancy or breastfeeding.
• Alcohol abuse or substance dependence.
• Intra-articular corticosteroid or hyaluronic acid injection into the affected knee within 6 months before study enrollment.
• History of knee surgery or knee arthroscopy.
• Signs of knee joint infection, including swelling, heat, redness, and systemic inflammatory response.
• Severe radiographic knee osteoarthritis, Kellgren-Lawrence grade 4.
• History of allergy, anaphylaxis, or contraindication to thread-embedding acupuncture or electroacupuncture according to the Vietnamese Ministry of Health technical guidance for traditional medicine procedures, including acute illness, severe debility, pregnancy, inflammatory or dermatological lesions at the treatment site, or allergy to absorbable thread.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• Dong Nai Traditional Medicine Hospital: collaborator

Study Sites (1)

Dong Nai Traditional Medicine Hospital

Đông Nãi, Bien Hoa, 76139, Vietnam

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating physicians cannot be blinded because the two procedures are visibly and technically different. Outcome assessment will be performed by research staff who do not perform the interventions and are not involved in randomization. The random allocation list will be maintained by an independent statistician and will not be disclosed to the blinded outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: thread-embedding acupuncture or electroacupuncture. Both groups will receive the same background standard care during the 4-week intervention period.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 24, 2026
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: May 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

VN (1)