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.

NCT06620874 | Not Yet Recruiting

• 1 other identifier: 20240724R
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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. 1.Do STABHA or high-concentration glucose water injections provide better pain relief and improved knee function compared to saline?
2. 2.What side effects do participants experience with these treatments?
3. 3.Receive two ultrasound-guided injections over two weeks.
4. 4.Undergo 4 weeks of physical therapy.
5. 5.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

Keywords

medical collateral ligament (MCL); Knee osteoarthritis; prolotherapy; STABHA; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Knee Range of Motion

  Baseline, 1 month, and 3 months post-intervention

• KOOS Knee Outcome Score

  Baseline, 1 month, and 3 months post-intervention

Other Outcomes (1)

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

  Baseline, 1 month, and 3 months post-intervention

Study Arms (3)

STABHA Injection

EXPERIMENTAL

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

Biological: STABHA Injection

High-Concentration Glucose Water Injection

EXPERIMENTAL

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

Saline Injection

PLACEBO COMPARATOR

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

Other: Saline Injection

Interventions

STABHA Injection BIOLOGICAL

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

STABHA Injection

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

High-Concentration Glucose Water Injection

Saline Injection OTHER

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

Saline Injection

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Ting-an: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ting-an Chen

CONTACT

+886984-166-521; phoebe19910215@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share