Knee Osteoarthritis (OA)
Conditions
Keywords
Electroacupuncture, Knee osteoarthritis, Thread-embedding acupuncture
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.
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.
Interventions
PROCEDUREThread-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.
PROCEDUREElectroacupuncture
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
University of Medicine and Pharmacy at Ho Chi Minh City
Dong Nai Traditional Medicine Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
38 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total WOMAC Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WChange in Knee Pain Intensity on the Visual Analog ScaleOMAC Pain Subscale Score | Baseline, Week 2, and Week 4 | 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. |
Countries
Vietnam
Outcome results
None listed