Knee OsteoarthritisNCT07833462
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
A study testing Thread Embedding Acupuncture in people with Knee Osteoarthritis, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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)… Read more about this study
- Who is it for?
- Ages 51 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Thread Embedding Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Sep 2026to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Thread Embedding Acupuncture, Sham Thread Embedding Acupuncture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread Embedding AcupunctureDevice
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 Thread Embedding AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Name of Intervention Group is "TEA Group" / Thread Embedding Acupuncture | 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. Receives: Device: Thread Embedding Acupuncture |
| Name of Control Group is "Sham TEA 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. Receives: Device: Sham Thread Embedding Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before therapy, week 2, week 4, week 8
Secondary outcomes (1)
Change in ROM (Range of Motion)
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.
Measured: Before therapy, week 2, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start23 Sep 2026 (estimated)
- Primary completion18 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oki Rachma Agustin, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833462
- Sponsor's protocol ID
- 26-07-1149
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07833462
- Acronym / sponsor ID
- 26-07-1149
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Name of Intervention Group is "TEA Group" / Thread Embedding Acupuncture | Experimental | Device: Thread Embedding AcupunctureParticipants 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. |
| Name of Control Group is "Sham TEA Group" | Sham comparator | Device: Sham Thread Embedding AcupunctureParticipants 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. |
Who may qualify
- Ages
- 51 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thread Embedding AcupunctureParticipants 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. | Device | Name of Intervention Group is "TEA Group" / Thread Embedding Acupuncture |
| Sham Thread Embedding AcupunctureParticipants 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. | Device | Name of Control Group is "Sham TEA Group" |
Primary outcome
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).
1 secondary outcome
Change in ROM (Range of Motion)
Time frame: Before therapy, week 2, week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KPEK FKUI-RSCM principal investigator
Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread Embedding Acupuncture in people with Knee Osteoarthritis, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oki Rachma, MD (081311306681, oki.rachma@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Before therapy, week 2, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.