Comparison of the Efficacy of Ultrasound-Guided Injections of Saline, High-Concentration Dextrose, and Ligament Repair Agents for the Treatment of Medial Collateral Ligament Pathology in Degenerative Knee Osteoarthritis: A Randomized Double-Blind Trial.

NCT ID: NCT06620874

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-09-30

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.

Conditions

Medial Collateral Ligament Lesions; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

STABHA Injection

Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval.

Group Type: EXPERIMENTAL

STABHA Injection

Intervention Type: BIOLOGICAL

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

Participants will receive two ultrasound-guided high-concentration glucose water injections into the medial collateral ligament of the knee at a 2-week interval.

Group Type: EXPERIMENTAL

High-Concentration Glucose Water Injection

Intervention Type: 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

Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval.

Group Type: PLACEBO_COMPARATOR

Saline Injection

Intervention Type: OTHER

Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval

Interventions

STABHA Injection

Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval

Intervention Type: BIOLOGICAL

High-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

Intervention Type: OTHER

Saline Injection

Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval

Intervention Type: OTHER

Eligibility Criteria

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

1. Severe systemic disorders including cancer, uncontrolled diabetes mellitus, sepsis, or cardiopulmonary diseases.

2. History of anticoagulation therapy, knee injection over the past three months.

3. History of knee surgery or candidates for knee arthroplasty.

4. History of intolerance to prolotherapy.

5. Pregnancy.

6. Infectious arthritis, inflammatory joint diseases, joint dysplasia.

7. Body Mass Index (BMI) greater than 35 kg/m2.

8. Complete tear of medial collateral ligament under ultrasound.

9. Fracture or other causes of knee pain instead of osteoarthritis.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Ting-an

OTHER

Sponsor Role: lead

Responsible Party

Chen Ting-an

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ting-an Chen

Role: CONTACT

phoebe19910215@gmail.com

+886984-166-521

Other Identifiers

20240724R

Identifier Type: -

Identifier Source: org_study_id