Knee OsteoarthritisNCT06755697
Comparative Efficacy of Intra-articular vs. MRI-guided Extra-articular Dextrose Injections in Knee Osteoarthritis Management
A study testing Intra-articular US-guided hypertonic dextrose injection, IA group and Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group. in people with Knee Osteoarthritis and Glucose, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Glucose, Prolotherapy
- What is being tested?
- Intra-articular US-guided hypertonic dextrose injection, IA group and Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2025to 31 Dec 2028
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . age between 45 to 80 years old;
- . meet at least three of the six American College of Rheumatology (ACR) criteria, including age over 50 years, morning stiffness less than 30 minutes, crepitus in passive knee movements, bony tenderness, bony enlargement, and no palpable warmth;
- . radiologic grading of 2 or 3 according to Kellgren-Lawrence criteria;
- showing willingness to receive prolotherapy.
Who cannot join
- . severe systemic disorders including cancer, uncontrolled diabetes mellitus, sepsis, or cardiopulmonary diseases;
- . history of anticoagulation therapy, knee injection over the past three months;
- . history of knee surgery or candidates for knee arthroplasty;
- . history of drug abuse;
- . a history of intolerance to prolotherapy;
- . pregnancy;
Show all 9Show fewer
- . infectious arthritis, inflammatory joint diseases, joint dysplasia;
- Body Mass Index (BMI) greater than 35 kg/m2;
- . not suitable or no willing to received MRI examination of the knee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Lin-Fen Hsieh, M.D., +886-28332211 ext. 2538, M001026@ms.skh.org.tw
About this study
Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. The knee is one of the most easily injured joint in the body, and knee OA can become a chronic and disabling condition that pose a threat to not only the patient but also his or her caretakers and healthcare resources. The prevalence of knee OA is 5% - 15% in men over 60 years, and 10% - 25% in women aged more than 60.
Knee OA can result from injuries, diseases, or wear and tear from overuse. It refers to structural changes that affect subchondral bone, articular cartilage, menisci, ligaments, synovium, and other joint structures. Currently, there are several conservative management of knee OA, including physiotherapy (therapeutic exercise, diathermy, electrotherapy), oral or topical medications, intra-articular and extra-articular injections, and radiofrequency.
Read more
There are various substances used in injections for knee OA, among which are corticosteroid, platelet-rich plasma (PRP), AmnioFix, exosome, dextrose, and hyaluronic acid (HA). Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. The principle of hypertonic dextrose injection, "prolotherapy", is injection of small volumes of the irritant solution at or around the lesion in order to stimulate fibroblast and vascular proliferation, local tissue healing, reduction of joint instability, thus resulting in pain relief. Previous studies have demonstrated that prolotherapy resulted in clinically meaningful sustained improvement of function and pain in knee OA, and there were no severe adverse events related to hypertonic dextrose injection. A study in 2023 showed that among various dextrose concentrations, higher concentrations demonstrated greater improvement of knee OA, thus 20% dextrose is recommended.
Regarding the site of dextrose injection in knee OA, previous studies demonstrated comparable effects of intra-articular and extra-articular injections. The periarticular injections include points around the knee where periarticular nerves exit the joint capsule, and acupuncture points at upper medial and lateral parts of knee joint. A study in 2024 revealed that prolotherapy combining intra-articular with peri-articular perineural injection resulted in better pain alleviation and improvement in knee joint function in knee OA. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). Radiography is used to assess osteophytes, joint space narrowing, and subchondral sclerosis, but it has limited ability to detect synovial inflammation, joint effusion, soft tissue abnormalities, and early cartilage damage. US can be used to evaluate synovial fluid and cartilage thickness, but not deep structures (e.g. subchondral bone change, meniscus tear, and ACL tear, etc.). On the other hand, MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures (e.g. ACL, meniscus, etc) in knee OA. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous laxity, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations, and signs of ligamentous laxity also provides target for ligaments injection. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings.
Because the effectiveness of prolotherapy targeting lesion sites according to MRI findings has not been well established, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections. The investigators hypothesize that MRI could be a good choice for the guidance of prolotherapy targets.
Read the detailed description
Osteoarthritis (OA) is a serious worldwide public health concern, and there are several conservative management of knee OA. Evidence showed that intra-articular and extra-articular injections are beneficial for knee OA. Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous lesions, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings. Thus, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections.
- Conditions
- Knee Osteoarthritis, Glucose, Prolotherapy, MRI, Physical Therapy, Rehabilitation
- Being tested
- Intra-articular US-guided hypertonic dextrose injection, IA group, Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular US-guided hypertonic dextrose injection, IA groupOther
IA injection: 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected. The ultrasound transducer (L18-4, Philips EPI Q5) is placed transversely over the patient's suprapatellar pouch while the patient lies supine with the knee actively extended and ankle dorsiflexed. The injectate will be injected into the suprapatellar pouch via transverse view, in-plane, lateral-to-medial approach with a 3.8 cm 22-gauge needle under US guidance.
Physical therapy: The physical therapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 4 weeks.
Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group.Other
Patients in the EA group will receive MRI examination of the knee without contrast. Detailed physical examinations (PE) will also be done for each subject. The PEs include inspection, palpation for local tenderness and crepitus, signs of effusion, assessment of range of motion, provocative meniscal testing, and ligamentous tests for laxity. A total of 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected to the target areas which has been shown abnormal on MRI images with a 3.8 cm 22-gauge needle under US guidance. For lesions of the deep structures or bone marrow lesion, a 7-cm 23 or 21 gauge needles may be used. Same as the IA group, EA hypertonic dextrose injection will be done at the 0, 2nd, and 4th weeks, as well as physical therapy during the first 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular US-guided hypertonic dextrose injection, IA group | Active comparator | IA injection: 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected. The ultrasound transducer (L18-4, Philips EPI Q5) is placed transversely over the patient's suprapatellar pouch while the patient lies supine with the knee actively extended and ankle dorsiflexed. The injectate will be injected into the suprapatellar pouch via transverse view, in-plane, lateral-to-medial approach with a 3.8 cm 22-gauge needle under US guidance.
Physical therapy: The physical therapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 4 weeks. Receives: Other: Intra-articular US-guided hypertonic dextrose injection, IA group |
| Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group. | Active comparator | Patients in the EA group will receive MRI examination of the knee without contrast.
Detailed physical examinations (PE) will also be done for each subject. The PEs include inspection, palpation for local tenderness and crepitus, signs of effusion, assessment of range of motion, provocative meniscal testing, and ligamentous tests for laxity. (16) A total of 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected to the target areas which has been shown abnormal on MRI images with a 3.8 cm 22-gauge needle under US guidance. For lesions of the deep structures or bone marrow lesion, a 7-cm 23 or 21 gauge needles may be used. Same as the IA group, EA hypertonic dextrose injection will be done at the 0, 2nd, and 4th weeks, as well as physical therapy during the first 4 weeks. Receives: Other: Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario McMaster University Osteoarthritis Index（WOMAC）
The WOMAC is a questionnaire evaluating the severity of osteoarthritis using pain, stiffness, and function subscales. The WOMAC composite score is constructed as the weighted average of the 3 subscale scores, and it ranges from 0 (worst) to 100 (best) for depicting knee-related quality-of-life. For WOMAC, the minimal clinical important difference (MCID) for knee OA has been reported as a change of 12 points on a 0- to 100-mm visual analog scale. According to previous studies, WOMAC is responsive to clinical changes.
Measured: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
Secondary outcomes (4)
The pain visual analog scale (VAS)
The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The MCID of pain VAS for knee OA ranged from 10 to 19.9 points, according to previous studies.
Measured: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
The 36-item Short Form Health Survey (SF-36)
The general health status and quality of life will be measured with the SF-36. The SF-36 is composed of 8 subscales including the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score ranging from 0 to 100, and higher scores indicate better quality of life. A Chinese-language version will be used for which the psychometric properties have been established.
Measured: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
Timed Up and Go (TUG) test
TUG test is a measure of dynamic balance which has good inter-rater and test-retest reliability. During a TUG test, it is timed when a patient rises from a chair, walks 3 meters, turns and walks back, and then sits down again. The MCID of TUG test has been reported as 3.4 seconds in patients with lumbar stenosis.
Measured: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
Self-assessment of the treatment effect
Self-assessment of the treatment effect: Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=5, effective=4, same=3, worse=2, much worse=1). (This item is not evaluated at baseline.)
Measured: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start23 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Lin-Fen Hsieh, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755697
- Sponsor's protocol ID
- 20240717R
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Intra-articular vs. MRI-guided Extra-articular Dextrose Injections in Knee Osteoarthritis Management
- ClinicalTrials.gov ID
- NCT06755697
- Acronym / sponsor ID
- 20240717R
- Conditions
- Knee Osteoarthritis, Glucose, Prolotherapy, MRI, Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jan 2025 (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.
Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. The knee is one of the most easily injured joint in the body, and knee OA can become a chronic and disabling condition that pose a threat to not only the patient but also his or her caretakers and healthcare resources. The prevalence of knee OA is 5% - 15% in men over 60 years, and 10% - 25% in women aged more than 60.
Knee OA can result from injuries, diseases, or wear and tear from overuse. It refers to structural changes that affect subchondral bone, articular cartilage, menisci, ligaments, synovium, and other joint structures. Currently, there are several conservative management of knee OA, including physiotherapy (therapeutic exercise, diathermy, electrotherapy), oral or topical medications, intra-articular and extra-articular injections, and radiofrequency.
There are various substances used in injections for knee OA, among which are corticosteroid, platelet-rich plasma (PRP), AmnioFix, exosome, dextrose, and hyaluronic acid (HA). Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. The principle of hypertonic dextrose injection, "prolotherapy", is injection of small volumes of the irritant solution at or around the lesion in order to stimulate fibroblast and vascular proliferation, local tissue healing, reduction of joint instability, thus resulting in pain relief. Previous studies have demonstrated that prolotherapy resulted in clinically meaningful sustained improvement of function and pain in knee OA, and there were no severe adverse events related to hypertonic dextrose injection. A study in 2023 showed that among various dextrose concentrations, higher concentrations demonstrated greater improvement of knee OA, thus 20% dextrose is recommended.
Regarding the site of dextrose injection in knee OA, previous studies demonstrated comparable effects of intra-articular and extra-articular injections. The periarticular injections include points around the knee where periarticular nerves exit the joint capsule, and acupuncture points at upper medial and lateral parts of knee joint. A study in 2024 revealed that prolotherapy combining intra-articular with peri-articular perineural injection resulted in better pain alleviation and improvement in knee joint function in knee OA. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). Radiography is used to assess osteophytes, joint space narrowing, and subchondral sclerosis, but it has limited ability to detect synovial inflammation, joint effusion, soft tissue abnormalities, and early cartilage damage. US can be used to evaluate synovial fluid and cartilage thickness, but not deep structures (e.g. subchondral bone change, meniscus tear, and ACL tear, etc.). On the other hand, MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures (e.g. ACL, meniscus, etc) in knee OA. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous laxity, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations, and signs of ligamentous laxity also provides target for ligaments injection. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings.
Because the effectiveness of prolotherapy targeting lesion sites according to MRI findings has not been well established, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections. The investigators hypothesize that MRI could be a good choice for the guidance of prolotherapy targets.
Detailed description
Osteoarthritis (OA) is a serious worldwide public health concern, and there are several conservative management of knee OA. Evidence showed that intra-articular and extra-articular injections are beneficial for knee OA. Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous lesions, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings. Thus, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular US-guided hypertonic dextrose injection, IA group | Active comparator | Other: Intra-articular US-guided hypertonic dextrose injection, IA groupIA injection: 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected. The ultrasound transducer (L18-4, Philips EPI Q5) is placed transversely over the patient's suprapatellar pouch while the patient lies supine with the knee actively extended and ankle dorsiflexed. The injectate will be injected into the suprapatellar pouch via transverse view, in-plane, lateral-to-medial approach with a 3.8 cm 22-gauge needle under US guidance. Physical therapy: The physical therapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 4 weeks. |
| Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group. | Active comparator | Other: Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group.Patients in the EA group will receive MRI examination of the knee without contrast. Detailed physical examinations (PE) will also be done for each subject. The PEs include inspection, palpation for local tenderness and crepitus, signs of effusion, assessment of range of motion, provocative meniscal testing, and ligamentous tests for laxity. (16) A total of 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected to the target areas which has been shown abnormal on MRI images with a 3.8 cm 22-gauge needle under US guidance. For lesions of the deep structures or bone marrow lesion, a 7-cm 23 or 21 gauge needles may be used. Same as the IA group, EA hypertonic dextrose injection will be done at the 0, 2nd, and 4th weeks, as well as physical therapy during the first 4 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . age between 45 to 80 years old;
- . meet at least three of the six American College of Rheumatology (ACR) criteria, including age over 50 years, morning stiffness less than 30 minutes, crepitus in passive knee movements, bony tenderness, bony enlargement, and no palpable warmth;
- . radiologic grading of 2 or 3 according to Kellgren-Lawrence criteria;
- showing willingness to receive prolotherapy.
Key exclusion criteria (9 listed)
- . severe systemic disorders including cancer, uncontrolled diabetes mellitus, sepsis, or cardiopulmonary diseases;
- . history of anticoagulation therapy, knee injection over the past three months;
- . history of knee surgery or candidates for knee arthroplasty;
- . history of drug abuse;
- . a history of intolerance to prolotherapy;
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 |
|---|---|---|
| Intra-articular US-guided hypertonic dextrose injection, IA groupIA injection: 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected. The ultrasound transducer (L18-4, Philips EPI Q5) is placed transversely over the patient's suprapatellar pouch while the patient lies supine with the knee actively extended and ankle dorsiflexed. The injectate will be injected into the suprapatellar pouch via transverse view, in-plane, lateral-to-medial approach with a 3.8 cm 22-gauge needle under US guidance. Physical therapy: The physical therapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 4 weeks. | Other | Intra-articular US-guided hypertonic dextrose injection, IA group |
| Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group.Patients in the EA group will receive MRI examination of the knee without contrast. Detailed physical examinations (PE) will also be done for each subject. The PEs include inspection, palpation for local tenderness and crepitus, signs of effusion, assessment of range of motion, provocative meniscal testing, and ligamentous tests for laxity. A total of 5 ml of 20% dextrose (2ml vitagen in 2ml normal saline and 1ml 1% xylocain) will be injected to the target areas which has been shown abnormal on MRI images with a 3.8 cm 22-gauge needle under US guidance. For lesions of the deep structures or bone marrow lesion, a 7-cm 23 or 21 gauge needles may be used. Same as the IA group, EA hypertonic dextrose injection will be done at the 0, 2nd, and 4th weeks, as well as physical therapy during the first 4 weeks. | Other | Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group. |
Primary outcome
The Western Ontario McMaster University Osteoarthritis Index（WOMAC）
Time frame: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
The WOMAC is a questionnaire evaluating the severity of osteoarthritis using pain, stiffness, and function subscales. The WOMAC composite score is constructed as the weighted average of the 3 subscale scores, and it ranges from 0 (worst) to 100 (best) for depicting knee-related quality-of-life. For WOMAC, the minimal clinical important difference (MCID) for knee OA has been reported as a change of 12 points on a 0- to 100-mm visual analog scale. According to previous studies, WOMAC is responsive to clinical changes.
4 secondary outcomes
The pain visual analog scale (VAS)
Time frame: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
The 36-item Short Form Health Survey (SF-36)
Time frame: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
Timed Up and Go (TUG) test
Time frame: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
Self-assessment of the treatment effect
Time frame: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.
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 24 Apr 2026.
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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.
Lin-Fen Hsieh principal investigator
Shin Kong Wu Ho-Su Memorial 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 Intra-articular US-guided hypertonic dextrose injection, IA group and Extra-articular US-guided injection targeting MRI-positive lesion sites, EA group. in people with Knee Osteoarthritis and Glucose, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 Taiwan. 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. 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 Lin-Fen Hsieh (+886-28332211 ext. 2538, M001026@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario McMaster University Osteoarthritis Index（WOMAC） (time frame: Change between baseline and at 1.5 months, 3 months, 6 months after the beginning of the treatment.). 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 24 Apr 2026.