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NCT Number: 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.

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.

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Key information

Conditions

Medial Collateral Ligament Lesions Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

The patients should fulfill the following criteria:

  • 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.
  • Evidence of medial collateral ligament (MCL) pathology with incomplete injuries (grade I or II).
  • Willing to receive prolotherapy treatment.
  • Willing and able to complete all follow-ups and assessments in the randomized double-blind trial.

Exclusion criteria

  • The exclusion criteria are:
  • 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 intolerance to prolotherapy.
  • Pregnancy.
  • Infectious arthritis, inflammatory joint diseases, joint dysplasia.
  • Body Mass Index (BMI) greater than 35 kg/m2.
  • Complete tear of medial collateral ligament under ultrasound.
  • Fracture or other causes of knee pain instead of osteoarthritis.

Treatment and study plan

STABHA Injection

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

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

Primary outcomes

  1. Pain Reduction Using WOMAC Osteoarthritis Index

    Time frame: 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 outcomes

  1. Knee Range of Motion

    Time frame: 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

  2. KOOS Knee Outcome Score

    Time frame: 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 outcomes

  1. Change in Medial Collateral Ligament (MCL) Characteristics in Knee Ultrasound Examination

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting-an Chen

CONTACT

[email protected]

+886984-166-521

Sponsors and collaborators

Lead sponsor

Chen Ting-an

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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