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

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

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.

Study Overview

• Status: Completed
• Conditions: Collateral Ligament Injury of Stifle Joint
• Intervention / Treatment: Device: Arthrys (Collagen Peptide solution); Drug: Depo medrol

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• San Marino
  • RSM
    • Domagnano, RSM, San Marino, 47895
      • Tiss'You

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen Peptide Group; 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); one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point
Active Comparator: Cortison Group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tiss'You srl

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Knee Pain; Collateral Ligament Pain; Knee Instability; Sports Trauma; Collagen Peptide Injections; Ligament Healing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Collagen Peptide Ligament

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