Knee Osteoarthritis, Medial Collateral Ligament Lesions
Conditions
Keywords
medical collateral ligament (MCL), Knee osteoarthritis, prolotherapy, STABHA, rehabilitation
Brief summary
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: 1. Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline? 2. What side effects do participants experience with these treatments? 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: 1. Receive two ultrasound-guided injections over two weeks. 2. Undergo 4 weeks of physical therapy. 3. Return for follow-up assessments at 1 and 3 months, including the WOMAC osteoarthritis index, pain score, KOOS knee outcome score, knee range of motion, and knee ultrasound examination.
Interventions
BIOLOGICALSTABHA Injection
Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval
OTHERHigh-Concentration Glucose Water Injection
Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval
OTHERSaline Injection
Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval
Sponsors
Chen Ting-an
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- The patients should fulfill the following criteria: 1. Age between 45 to 80 years old. 2. 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. 3. Radiologic grading of 2 or 3 according to Kellgren-Lawrence criteria. 4. Evidence of medial collateral ligament (MCL) pathology with incomplete injuries (grade I or II). 5. Willing to receive prolotherapy treatment. 6. Willing and able to complete all follow-ups and assessments in the randomized double-blind trial.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction Using WOMAC Osteoarthritis Index | Baseline, 1 month, and 3 months post-intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Range of Motion | Baseline, 1 month, and 3 months post-intervention | The change in knee range of motion will be measured using a goniometer at baseline, 1 month, and 3 months after intervention |
| KOOS Knee Outcome Score | Baseline, 1 month, and 3 months post-intervention | The outcome will assess the change in KOOS Knee Outcome Score at baseline, 1 month, and 3 months after the treatment intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Medial Collateral Ligament (MCL) Characteristics in Knee Ultrasound Examination | Baseline, 1 month, and 3 months post-intervention | 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. |
Contacts
Primary ContactTing-an Chen
Outcome results
None listed