A.O.U.P. P. Giaccone, Palermo, Italia
Palermo, Italia, 90127, Italy
NCT Number: NCT06890247
: 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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Observational
Palermo, Italia, 90127, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Baseline (T0), 30 days (T2), and 90 days (T3).
Evaluation of changes in the Lequesne Index, a validated tool that measures functional disability in knee osteoarthritis patients. The index assesses pain, maximum walking distance, and daily activities. Scores range from 0 (no disability) to a maximum score indicating severe disability. Higher scores denote worse functional impairment. Measurements will be recorded at baseline (T0), 30 days (T2), and 90 days (T3).
Time frame: Baseline (T0) and 90 days (T3).
Assessment of changes in quality of life using the SF-12 Health Survey, which evaluates both physical and mental health components. The SF-12 generates composite scores for these domains, with higher scores indicating better quality of life. Measurements will be taken at Baseline (T0) and compared to 90 days (T3) post-intervention to assess the impact of the treatment.
Time frame: Baseline (T0) and 90 days (T3).
Measurement of muscle strength parameters, including peak torque, endurance, and total work of the knee flexor and extensor muscles, using isokinetic dynamometry. Testing will be performed at three angular velocities (0°, 60°, and 120°/sec). Data collected at Baseline (T0) will be compared to follow-up measurements at 90 days (T3) to evaluate the functional improvement in muscle performance.
Contact information is provided by the study sponsor or research team.
University of Palermo
Other
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
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