Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain

Study Overview
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Brief Summary
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Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National Hospital, the study investigates a new approach to treating persistent collateral ligament pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen peptide injections, a treatment that addresses pain and inflammation in ways previous methods have not. The study involves a randomized controlled trial with 62 patients, all diagnosed with inflammation in the collateral ligament site. The patients are split into two groups: one receiving collagen injections alongside oral painkillers and the other receiving depo-medrol injections with oral painkillers.

Official Title
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Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial

Conditions
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Collateral Ligament Injury of Stifle Joint

Intervention / Treatment
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* Device: Arthrys (Collagen Peptide solution)
* Drug: Depo medrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 18 years, lateral knee pain with a duration of 3 months or longer, ultrasound evidence of inflammation of the femoral condyle attachment point, agreement to participate in the study Exclusion Criteria: trauma, infection, dermatitis at the site of the inflammation, damage to surrounding knee structures, history of chronic inflammatory arthritis (such as gout or rheumatoid arthritis), local corticosteroid injection within 3 months before participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen Peptide Group<br>The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle). | Device: Arthrys (Collagen Peptide solution)<br>* one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point<br>|
| Active Comparator: Cortison Group<br>The Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months. | Drug: Depo medrol<br>* one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analogue Pain) | Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain) | Baseline, 3 months, 6 months | 
| Ultrasound | Ultrasound evaluation for hypoechoic (signal reduction), normal, and hyperechoic (signal amplification) ligaments. Hypoechoic signal suggests damage or degeneration of the ligament; normal signal suggests healthy ligament tissue; hyperechoic signal suggests calcification, scar, or inflammation. | Baseline, 3 months, 6 months | 
| Likert | Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction) | Baseline, 6 months | 
| WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collateral Ligament Pain, Knee Pain, Knee Instability, Sports Trauma, Collagen Peptide Injections, Ligament Healing