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

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