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The goal of this clinical trial is to evaluate the effectiveness of STABHA, high-concentration glucose water, and saline injections in treating knee osteoarthritis with medial collateral ligament lesions. This prospective, double-blind, randomized trial will recruit 51 patients from the Shin Kong Hospital Rehabilitation Department.
The main questions it aims to answer are:
Participants will be randomly divided into three groups: STABHA, high-concentration glucose water, and saline. In addition to routine intra-articular hyaluronic acid injections, each group will receive two ultrasound-guided injections of their assigned treatment into the medial collateral ligament of the knee, with a two-week interval. All participants will also undergo a 4-week physical therapy program.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STABHA Injection | Experimental | Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval. |
|
| High-Concentration Glucose Water Injection | Experimental | Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval. |
|
| Saline Injection | Placebo Comparator | Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STABHA Injection | Biological | Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction Using WOMAC Osteoarthritis Index | The primary outcome will assess the change in pain scores using the WOMAC Osteoarthritis Index at baseline, 1 month, and 3 months after the treatment intervention | Baseline, 1 month, and 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Range of Motion | The change in knee range of motion will be measured using a goniometer at baseline, 1 month, and 3 months after intervention | Baseline, 1 month, and 3 months post-intervention |
| KOOS Knee Outcome Score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medial Collateral Ligament (MCL) Characteristics in Knee Ultrasound Examination | The outcome will assess changes in the characteristics of the medial collateral ligament (MCL) of the knee using ultrasound examination. Measurements will include MCL thickness, echogenicity, and presence of any structural abnormalities (e.g., calcifications, tears). Ultrasound evaluations will be performed at baseline, 1 month, and 3 months after the intervention to determine the treatment effects on MCL condition. |
Inclusion Criteria:
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The patients should fulfill the following criteria:
Exclusion Criteria:
The exclusion criteria are:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting-an Chen | Contact | +886984-166-521 | phoebe19910215@gmail.com |
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| High-Concentration Glucose Water Injection | Other | Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval |
|
| Saline Injection | Other | Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval |
|
The outcome will assess the change in KOOS Knee Outcome Score at baseline, 1 month, and 3 months after the treatment intervention
| Baseline, 1 month, and 3 months post-intervention |
| Baseline, 1 month, and 3 months post-intervention |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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