Knee Osteoarthritis (OA)NCT07665125
Electroacupuncture Versus Thread-Embedding Acupuncture for Knee Osteoarthritis
A study testing Thread-Embedding Acupuncture and Electroacupuncture in people with Knee Osteoarthritis (OA), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 years and older
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- Thread-Embedding Acupuncture and Electroacupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Dong Nai Traditional Medicine Hospital
Đông Nãi, Bien Hoa, 76139
About this study
Official title: Effectiveness of Electroacupuncture and Thread-Embedding Acupuncture in Patients With Knee Osteoarthritis: A Randomized, Assessor-Blinded, Parallel-Group Controlled Trial
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.
Read the detailed description
Knee osteoarthritis is a common chronic degenerative joint disorder characterized by pain, stiffness, reduced mobility, and impaired physical function. Non-pharmacological interventions are important in the management of knee osteoarthritis, particularly for patients in whom long-term pharmacological treatment is limited by comorbidities or adverse effects.
Electroacupuncture is an acupuncture technique in which electrical stimulation is applied through inserted acupuncture needles. Thread-embedding acupuncture is a specialized acupuncture-related procedure in which absorbable catgut thread is inserted into acupuncture points to provide prolonged stimulation. Both interventions are used in traditional medicine practice for musculoskeletal pain, but direct comparative evidence between these two approaches in knee osteoarthritis remains limited.
This trial is designed as a randomized, controlled, assessor-blinded, two-arm parallel-group study with balanced allocation. Participants who meet eligibility criteria and provide written informed consent will be randomly allocated to either the thread-embedding acupuncture group or the electroacupuncture group. Outcome assessors will be blinded to treatment assignment. Due to the procedural characteristics of the interventions, blinding of participants and care providers is not feasible.
Participants in both groups will receive standard background care during the 4-week treatment period, consisting of lifestyle modification advice and therapeutic ultrasound. The thread-embedding acupuncture group will receive catgut thread embedding once every 2 weeks for a total of 2 sessions. The electroacupuncture group will receive electroacupuncture 5 sessions per week for 4 weeks, for a total of 20 sessions. Outcomes will be assessed at baseline, Week 2, and Week 4, with patient-reported global improvement and treatment satisfaction assessed at Week 4.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- Thread-Embedding Acupuncture, Electroacupuncture
- Keywords
- Electroacupuncture, Knee osteoarthritis, Thread-embedding acupuncture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-Embedding AcupunctureProcedure or surgery
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.
ElectroacupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, and Week 4
Secondary outcomes (1)
Change in WChange in Knee Pain Intensity on the Visual Analog ScaleOMAC Pain Subscale Score
Pain intensity will be assessed using a 100-mm Visual Analog Scale, where 0 indicates no pain and 100 indicates the worst imaginable pain. Participants will self-rate knee pain intensity at each assessment time point.
Measured: Baseline, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Oct 2025
- Primary completion30 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Collaborators
- Dong Nai Traditional Medicine Hospital
- Responsible party
- Principal investigator, Hoang Trong Dao, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665125
- Sponsor's protocol ID
- 495/ĐHYD-HĐĐĐ
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electroacupuncture and Thread-Embedding Acupuncture in Patients With Knee Osteoarthritis: A Randomized, Assessor-Blinded, Parallel-Group Controlled Trial
- ClinicalTrials.gov ID
- NCT07665125
- Acronym / sponsor ID
- 495/ĐHYD-HĐĐĐ
- Conditions
- Knee Osteoarthritis (OA)
- Keywords
- Electroacupuncture, Knee osteoarthritis, Thread-embedding acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Dong Nai Traditional Medicine Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Knee osteoarthritis is a common chronic degenerative joint disorder characterized by pain, stiffness, reduced mobility, and impaired physical function. Non-pharmacological interventions are important in the management of knee osteoarthritis, particularly for patients in whom long-term pharmacological treatment is limited by comorbidities or adverse effects.
Electroacupuncture is an acupuncture technique in which electrical stimulation is applied through inserted acupuncture needles. Thread-embedding acupuncture is a specialized acupuncture-related procedure in which absorbable catgut thread is inserted into acupuncture points to provide prolonged stimulation. Both interventions are used in traditional medicine practice for musculoskeletal pain, but direct comparative evidence between these two approaches in knee osteoarthritis remains limited.
This trial is designed as a randomized, controlled, assessor-blinded, two-arm parallel-group study with balanced allocation. Participants who meet eligibility criteria and provide written informed consent will be randomly allocated to either the thread-embedding acupuncture group or the electroacupuncture group. Outcome assessors will be blinded to treatment assignment. Due to the procedural characteristics of the interventions, blinding of participants and care providers is not feasible.
Participants in both groups will receive standard background care during the 4-week treatment period, consisting of lifestyle modification advice and therapeutic ultrasound. The thread-embedding acupuncture group will receive catgut thread embedding once every 2 weeks for a total of 2 sessions. The electroacupuncture group will receive electroacupuncture 5 sessions per week for 4 weeks, for a total of 20 sessions. Outcomes will be assessed at baseline, Week 2, and Week 4, with patient-reported global improvement and treatment satisfaction assessed at Week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thread-Embedding Acupuncture | Experimental | Procedure: Thread-Embedding AcupunctureParticipants 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. |
| Electroacupuncture | Active comparator | Procedure: ElectroacupunctureParticipants 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. |
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thread-Embedding AcupunctureThread-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 or surgery | Thread-Embedding Acupuncture |
| ElectroacupunctureElectroacupuncture 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. | Procedure or surgery | Electroacupuncture |
Primary outcome
Change in Total WOMAC Score
Time frame: Baseline, Week 2, and Week 4
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.
1 secondary outcome
Change in WChange in Knee Pain Intensity on the Visual Analog ScaleOMAC Pain Subscale Score
Time frame: Baseline, Week 2, and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread-Embedding Acupuncture and Electroacupuncture in people with Knee Osteoarthritis (OA), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total WOMAC Score (time frame: Baseline, Week 2, and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.