Clinical trial NCT05450458: Hyaluronic Acid in Overuse Knee Pain
Official title: Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Overuse Injury
Keywords: KNEE
PAIN
SPORTSMEN
HYALURONIC ACID
Lead sponsor: Hospital Regional Tlalnepantla
Sponsor class: OTHER_GOV
First posted: 2022-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.
Primary purpose: TREATMENT

Brief summary: Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.

Detailed description: Sports activities have become a fundamental part of our daily life, this has led to an overuse of load joints, being the knee the most relevant. Overuse injuries of the knee result from microtrauma associated with physical activity and exercise that exceeds the strength of the cartilage tissue.

The purpose of this study is to evaluate the usefulness and safety of hyaluronic acid in athlete patients with knee overuse syndrome. Investigators hypothesis is that hyaluronic acid y safe and can improve symptoms of knee pain in sports patients. . Scores recorder data will be made at 15 days, then at 3 and 6 months after two knee injections of hyaluronic acid with sorbitol (Synolis VA).

Synolis VA is a viscoelastic, sterile, non-pyrogenic, isotonic, buffered solution of 2% hyaluronic acid. The hyaluronic acid used in synolis VA is obtained from bacterial fermentation and has a high molecular weight of 2 mdaltons, it has a neutral pH of 6.8 - 7.4 like synovial fluid. High concentration and high molecular weight of hyaluronic acid combined with sorbitol limits its degradation and confers the capacity of viscoelastic solution to restore joint lubrication and shock absorption properties.

This research protocol has been approve by the ethics and research Institutional committee in ISSEMyM Tlalnepantla Estado de Mexico number: CEI/0504/PI./2022. All participants must sign a informed consent to confirm be part fo this study.

Eligibility criteria: Inclusion Criteria:

* - Patients with knee pain for more than 3 months
* Patients between 30 and 55 years old
* Patients without a history of previous knee joint surgery.
* Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases.
* Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment.
* Patients without a history of allergies to non-steroidal anti-inflammatory drugs.
* Patients with no history of infection in or around the knee.

Exclusion Criteria:

* - Patients who cannot be categorized as social athletes.
* Patients with an associated sports injury that limits their sports practice.
* Patients who have a treatment associated with knee pain independent of that established in the study protocol.

Primary outcomes:
measure: Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the knee injury and osteoarthritis outcome score
timeFrame: 6 Months
measure: Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the International Knee Documentation Committee score
timeFrame: 6 Months
Secondary outcomes:
measure: Safety of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome by the number of adverse effects in participants.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tlanepantla
country: Mexico
facility: Issemym Tlalnepantla
Study officials:
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