Single-dose Intra-Articular of a Hybrid Purified Hyaluronic Acid with a High Molecular Weight and Sodium Chondroitin of Biotechnological Origin in Combination with Rehabilitation Treatment in Sports Adults with Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days
研究概览
简要总结
: This observational case-control study aims to evaluate the efficacy of a single-dose intra-articular injection of a hybrid purified hyaluronic acid with high molecular weight and sodium chondroitin of biotechnological origin, combined with rehabilitation treatment, in sports adults with moderate to severe knee osteoarthritis. Additionally, the study incorporates isokinetic testing to assess muscle strength and functional capacity.
The primary objective is to determine whether this combined treatment improves pain relief, functional capacity, and overall quality of life compared to rehabilitation treatment alone. Participants aged 18 to 50 years, diagnosed with knee osteoarthritis, will be recruited from clinics at the U.O.C. of Recovery and Functional Rehabilitation at A.O.U.P. P. Giaccone in Palermo. Participants will be divided into two groups: one receiving the hybrid hyaluronic acid and sodium chondroitin injection along with rehabilitation, and the other receiving only rehabilitation. The study will also utilize isokinetic testing to provide objective measurements of muscle strength and endurance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 50 years.
- •Radiologically confirmed diagnosis of knee osteoarthritis (Kellgren-Lawrence grade ≤3), present for at least 6 months.
- •Persistent moderate to severe pain due to osteoarthritis, interfering with physical performance.
- •Documented reduction in sports performance (use appropriate scales or tests to validate this).
- •Lack of response to pharmacological or other conservative treatments.
- •Willingness to provide written informed consent for participation.
排除标准
- •Coexisting rheumatic diseases.
- •History of intra-articular viscosupplementation in the target knee within the previous 6 months.
- •Presence of significant venous or lymphatic stasis.
- •Body Mass Index (BMI) ≥ 30 kg/m².
- •Use of systemic or intra-articular corticosteroids in the target knee within the last 3 months.
- •Chronic use of topical/systemic analgesics, NSAIDs, or narcotics.
- •History of alcohol or drug abuse.
- •Allergy or hypersensitivity to hyaluronic acid or any of its components.
- •Pregnant or breastfeeding women, or those not using adequate contraception.
结局指标
主要结局
Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days
时间窗: From baseline (T0) to 90 days (T3) post-intervention
The primary outcome will assess the change in pain intensity using the Numerical Rating Scale (NRS). This scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Pain intensity will be measured at baseline (T0) and at 90 days (T3) following the intervention. The change in NRS scores between these time points will quantify the treatment's effectiveness in reducing knee pain among study participants. Participants with a clinically meaningful reduction in pain (defined as a decrease of at least 2 points on the NRS) will be considered responders.
次要结局
- Change from Baseline in Functional Capacity Assessed by Lequesne Index at 30 and 90 Days(Baseline (T0), 30 days (T2), and 90 days (T3).)
- Change from Baseline in Quality of Life Assessed by SF-12 Questionnaire(Baseline (T0) and 90 days (T3).)
- Change from Baseline in Muscle Strength Evaluated with Isokinetic Testing(Baseline (T0) and 90 days (T3).)
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo