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

Sponsor

Tiss'You srl (Industry)

Overall Status

Completed

CT.gov ID

NCT05971004

Collaborator

(none)

Enrollment

Location

Arms

11.7

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Collateral Ligament Injury of Stifle Joint	Device: Arthrys (Collagen Peptide solution) Drug: Depo medrol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 13, 2022

Actual Primary Completion Date :

Oct 10, 2022

Actual Study Completion Date :

Apr 4, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.