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

October 4, 2026 updated by: Oki Rachma Agustin, Universitas Indonesia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Knee osteoarthritis is a chronic degenerative joint disease associated with knee pain, stiffness, functional limitation, and reduced quality of life. Although pharmacological and non-pharmacological treatments are available, some patients may experience limitations related to treatment duration, adverse effects, or the need for repeated treatment.

Thread embedding acupuncture is an acupuncture modality in which an absorbable thread, such as polydioxanone (PDO), is inserted into selected acupuncture points to provide prolonged mechanical and biological stimulation. Previous studies have investigated thread embedding acupuncture for knee osteoarthritis using various local acupuncture points. However, the use of a longitudinal oblique technique from BL40 toward BL57 has been limited in previous clinical studies.

This study is designed to evaluate the efficacy of thread embedding acupuncture using a longitudinal oblique technique from BL40 toward BL57 in patients with knee osteoarthritis. The intervention is based on a proposed neurophysiological, neuromuscular, neurovascular, and myofascial rationale involving the posterior aspect of the lower extremity.

This study is a double-blind, randomized controlled trial with a parallel-group design. A total of 44 participants will be recruited and randomly allocated in a 1:1 ratio into two groups using permuted block randomization with a block size of four. The intervention group will receive thread embedding acupuncture, while the control group will receive sham thread embedding acupuncture.

Participants will be men and women aged 51 to 70 years with bilateral knee osteoarthritis diagnosed clinically and radiologically according to the American College of Rheumatology criteria and with Kellgren-Lawrence grade II or III osteoarthritis. Participants must have a Numeric Rating Scale pain score greater than 3 during activity and must be able to complete the KOOS questionnaire.

In the intervention group, polydioxanone (PDO) thread, 26G × 60 mm, will be inserted bilaterally at BL40 using a longitudinal oblique technique directed toward BL57 at an insertion angle of approximately 15 degrees to the skin surface. The procedure will be performed by a physician trainee in medical acupuncture with a minimum competency level of three. Anatomical landmarks in the popliteal region will be identified before insertion, and body mass index and individual anatomical characteristics will be considered as safety factors.

In the control group, a 0.25 × 25 mm acupuncture needle will be inserted bilaterally at BL40 using a similar longitudinal oblique approach at approximately 15 degrees to the skin surface and then immediately withdrawn without thread implantation.

Participants will be evaluated at baseline and at weeks 2, 4, and 8 after the intervention. KOOS will be assessed at baseline and at weeks 2, 4, and 8. Knee ROM, including flexion and extension, will be measured using a goniometer at baseline and at weeks 2 and 8.

The primary clinical outcomes of interest are changes in KOOS and knee ROM following the intervention. Safety will also be monitored, including local pain, bleeding, hematoma, swelling, infection, allergic or inflammatory reactions, and potential neurovascular complications associated with the procedure.

Participants in the control group will be offered actual thread embedding acupuncture after completion of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

51 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Name of Intervention Group is "TEA Group" / Thread Embedding Acupuncture

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

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.
Sham Comparator: Name of Control Group is "Sham TEA Group"

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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Before therapy, week 2, week 4, week 8

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in ROM (Range of Motion)
Time Frame: Before therapy, week 2, week 8

Knee ROM will be assessed using a goniometer by measuring maximum knee flexion and extension in degrees. Measurements will be performed three times by the assessor, and the mean value will be recorded. Change in maximum knee flexion and extension ROM measured using a goniometer in degrees. Measurements are performed three times by the assessor, and the mean value is recorded.
Before therapy, week 2, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitas Indonesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KPEK FKUI-RSCM, Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-07-1149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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