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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Peptide Group | Experimental | 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 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrys (Collagen Peptide solution) | Device | one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiss'You | Domagnano | RSM | 47895 | San Marino |
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| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Depo medrol | 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. |
|
| 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 |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |