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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Medial Collateral Ligament Lesions
• Intervention / Treatment: Biological: STABHA Injection; Other: High-Concentration Glucose Water Injection; Other: Saline Injection

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting-an Chen; Phone Number: +886984-166-521; Email: phoebe19910215@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STABHA Injection; Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval.	Biological: STABHA Injection; Participants will receive two ultrasound-guided STABHA injections into the medial collateral ligament of the knee at a 2-week interval
Experimental: 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.	Other: 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
Placebo Comparator: Saline Injection; Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval.	Other: Saline Injection; Participants will receive two ultrasound-guided saline injections into the medial collateral ligament of the knee at a 2-week interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	Baseline, 1 month, and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Chen Ting-an

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 28, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; Knee osteoarthritis; prolotherapy; medical collateral ligament (MCL); STABHA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 20240724R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No