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

Not Applicable

Completed

• Conditions: Collateral Ligament Injury of Stifle Joint
• Interventions: Device: Arthrys (Collagen Peptide solution); Drug: Depo medrol

• Registration Number: NCT05971004
• Lead Sponsor: Tiss'You srl

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-13
• Primary Completion: 2022-10-10
• Study Completion: 2023-04-04
• Status Verified: 2023-07
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-30
• Last Update Submitted: 2023-07-30
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen Peptide Group	Arthrys (Collagen Peptide solution)	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).
Cortison Group	Depo medrol	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.

Primary Outcome Measures

Name	Time	Method
WOMAC	6 months	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.

Secondary Outcome Measures

Name	Time	Method
VAS (Visual Analogue Pain)	Baseline, 3 months, 6 months	Visual Analogue Pain assessing pain from 0 (no pain) to 10 (unbearable pain)
Ultrasound	Baseline, 3 months, 6 months	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.
Likert	Baseline, 6 months	Likert scale for patients' satisfaction from 1 (no statisfaction) to 5 (maximum satisfaction)
WOMAC	Baseline, 3 months	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.

Trial Locations

Locations (1)

Tiss'You; 🇸🇲 Domagnano, RSM, San Marino