Clinical trial NCT06620874: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Medial Collateral Ligament Lesions
Knee Osteoarthritis
Keywords: medical collateral ligament (MCL)
Knee osteoarthritis
prolotherapy
STABHA
rehabilitation
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

* The exclusion criteria are:

  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.

Primary outcomes:
measure: Pain Reduction Using WOMAC Osteoarthritis Index
timeFrame: Baseline, 1 month, and 3 months post-intervention
Secondary outcomes:
measure: Knee Range of Motion
timeFrame: Baseline, 1 month, and 3 months post-intervention
measure: KOOS Knee Outcome Score
timeFrame: Baseline, 1 month, and 3 months post-intervention
Other outcomes:
measure: Change in Medial Collateral Ligament (MCL) Characteristics in Knee Ultrasound Examination
timeFrame: Baseline, 1 month, and 3 months post-intervention
Locations:
Study officials:
References: