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

NCT ID: NCT05971004

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2023-04-04

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.

Conditions

Collateral Ligament Injury of Stifle Joint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Arthrys (Collagen Peptide solution)

Intervention Type: DEVICE

one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point

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.

Group Type: ACTIVE_COMPARATOR

Depo medrol

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tiss'You srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Prof. Binh Luu Thi

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tiss'You

Domagnano, RSM, San Marino

Countries

San Marino

Other Identifiers

Collagen Peptide Ligament

Identifier Type: -

Identifier Source: org_study_id