Efficacy of Thread-Embedding Acupuncture Using the Longitudinal Oblique Technique From BL40 Toward BL57 on KOOS Scores and Joint Range of Motion in Knee Osteoarthritis
- NCT ID
- NCT07833462
- Registry status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Universitas Indonesia
- Conditions
- Knee Osteoarthritis
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 44 participants (Estimated).
What is being studied
- Device: Sham Thread Embedding Acupuncture
- Device: Thread Embedding Acupuncture
Who may be eligible
- Ages
- 51 Years to 70 Years
- Sex
- All
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* Male and female patients aged 51 to 70 years.
* Clinically and radiologically diagnosed with bilateral knee osteoarthritis according to ACR (American College of Rheumatology) criteria.
* Kellgren-Lawrence grade II or III knee osteoarthritis.
* NRS (Numeric Rating Scale) score \>3 during activity (activities of daily living or light exercise).
* Body Mass Index (BMI) ≥18.5 kg/m².
* Knee functional limitations assessable via the KOOS.
* Ability to understand and complete the KOOS questionnaire. MMSE score \>23 (normal or no significant cognitive impairment).
* Willingness to complete the study and sign the informed consent form.
Exclusion Criteria:
* History of knee surgery such as total knee replacement, arthroscopy, or ligament reconstruction.
* Inflammatory joint disease or autoimmune conditions (e.g., rheumatoid arthritis, gouty arthritis, spondyloarthritis, or lupus arthritis) assessed via clinical symptoms and/or radiological findings.
* Presence of a tumor, wound, or local infection at the injection site.
* History of peripheral vascular disease, DVT/thromboembolism, aneurysm or pseudoaneurysm, or coagulation/bleeding disorders.
* Presence of a blood disorder or use of blood thinners (combination antiplatelet or anticoagulant therapy) with an INR ≤ 2.0; history of spontaneous bleeding, thrombocytopenia, or coagulation disorders.
* Uncontrolled diabetes mellitus or severe systemic disease with a random blood glucose (RBG) level ≥200 mg/dL (measured via capillary blood using a glucometer).
Random blood glucose (RBG) level ≥200 mg/dL in non-diabetic patients (measured via capillary blood using a glucometer for all study participants).
* History of keloids.
* Routine use of steroids or NSAIDs, or use of topical analgesics prior to therapy and during the study period.
* Not currently receiving intra-articular knee injections (corticosteroids or hyaluronic acid) and has not received them in the last 3 months.
* Presence of a Baker's cyst in the popliteal fossa, identified during physical examination.
* Patients currently undergoing physiotherapy or who have undergone it within the last month.
* Prior receipt of thread-embedding acupuncture therapy in the knee area or at acupuncture points BL40-BL57 within the last 6 months, or other forms of acupuncture within the last 2 weeks.
* History of hypersensitivity or allergic reactions to polydioxanone (PDO) threads or procedure needle materials (e.g., stainless steel).
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Indonesia
- DKI Jakarta, Indonesia: 1
Sample of listed locations
- Universitas Indonesia — Jakarta Pusat, DKI Jakarta, 10430, Indonesia — Site recruitment status not specified in the registry data
Study details
- Start date
- September 23, 2026
- Primary completion date
- November 18, 2026
- Completion date
- November 25, 2026
- First posted
- September 22, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07833462
- Registry last updated
- October 7, 2026
- QualifiedStudies registry data refreshed
- October 12, 2026
- QualifiedStudies record fetched
- October 12, 2026
View NCT07833462 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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