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

NCT07833462 | Not Yet Recruiting

• 1 other identifier: 26-07-1149
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of thread embedding acupuncture using a longitudinal oblique technique from BL40 toward BL57 in patients with knee osteoarthritis. The effects of the intervention will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and knee range of motion (ROM), compared with sham thread embedding acupuncture in a double-blind randomized controlled trial.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS is a 42-item patient-reported outcome questionnaire consisting of five subscales: Pain (9 items), Symptoms (7 items), Activities of Daily Living (17 items), Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). Each subscale is scored from 0 to 100, with higher scores indicating better knee-related health status. Change in KOOS from baseline, assessing knee pain, symptoms, activities of daily living, sport and recreational activities, and knee-related quality of life. KOOS will be assessed at baseline and at weeks 2, 4, and 8 after intervention. Changes in KOOS scores from baseline will be evaluated at each follow-up time point (week 2, week 4, and week 8).

  Before therapy, week 2, week 4, week 8

Secondary Outcomes (1)

• Change in ROM (Range of Motion)

  Before therapy, week 2, week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants randomized to the experimental group will receive bilateral thread embedding acupuncture at BL40 using a longitudinal oblique technique toward BL57. A sterile 26G × 60 mm needle containing monofilament PDO thread will be inserted at approximately 15° toward the distal posterior lower leg. BL40 will be identified at the midpoint of the popliteal crease, with anatomical palpation before insertion. EMLA® cream will be applied under occlusion for 60 minutes. BMI, height, weight, and individual anatomy will be considered for safety. The needle will be withdrawn after PDO implantation, leaving the thread completely buried beneath the skin. No redirection or aggressive manipulation will be performed. The procedure will stop if abnormal neurological symptoms occur. Pressure, antiseptic care, and sterile dressing will follow, with post-procedure monitoring for adverse events.

Device: Thread Embedding Acupuncture

Control Group

SHAM COMPARATOR

Participants randomized to the sham comparator group will receive sham acupuncture at bilateral BL40 in the prone position. BL40 will be identified at the midpoint of the popliteal crease, followed by aseptic and antiseptic preparation with 4% chlorhexidine gluconate. EMLA® cream will be applied under plastic wrap for 60 minutes. A sterile 0.25 × 25 mm manual acupuncture needle will be inserted bilaterally at BL40 using a longitudinal oblique technique toward the distal posterior lower leg in the direction of BL57 at approximately 15°. The needle will be rapidly withdrawn without PDO implantation. Pressure will be applied for 10 seconds or until bleeding stops, followed by antiseptic care and sterile plaster. Participants will be monitored for adverse events and undergo the same outcome assessments. After study completion, the sham group may receive actual thread embedding acupuncture.

Device: Sham Thread Embedding Acupuncture

Interventions

Thread Embedding Acupuncture DEVICE

Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.

Intervention Group

Sham Thread Embedding Acupuncture DEVICE

Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.

Control Group

Eligibility Criteria

• Age: 51 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitas Indonesia: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• KPEK FKUI-RSCM

  Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oki Rachma, MD

CONTACT

081311306681; oki.rachma@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a parallel-group, double-blind, randomized controlled trial in 44 patients with knee osteoarthritis, randomized 1:1 to thread embedding acupuncture or sham acupuncture. The intervention group receives bilateral BL40 thread embedding using a 26G × 60 mm PDO needle, inserted obliquely toward BL57 at approximately 15°. EMLA cream is applied under occlusion for 60 minutes. The control group receives bilateral BL40 using a 0.25 × 25 mm needle with the same technique and angle, but without PDO implantation, followed by immediate withdrawal. Both groups receive the same safety monitoring and outcome assessments.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 23, 2026
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)