Comparison of the effect of intra-articular hypertonic saline, intra-articular HIALGAN and physiotherapy in patients with knee arthritis

Phase 3

Conditions: Knee osteoarthritis.
Osteoarthritis of knee

Registration Number: IRCT20190309042989N1

Lead Sponsor: Artesh University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 90

Inclusion Criteria

ACR criteria (age more than 50 years old / cryptasion or morning stiffness less than 30 minutes / presence of radiographic evidence / presence of symptoms for more than three months)
K-L radiographic criteria : grade 2-4

Exclusion Criteria

Patient dissatisfaction
Other joint arthritis in the knee joint including rheumatoid arthritis and gout or systemic neuromuscular disorders such as Myasthenia Gravis, Eton-Lambert syndrome and ALS.
History of total Knee arthroplasty
History of fracture in the knee bones
Intra-articular corticosteroid injection over the past 2 weeks, history of hyaluronic acid injection or proletherapy over the past one year
Any contraindication for intra-articular injection such as thrombocytopenia , coagulation disorder, joint infections, skin infections at the injection site
Dysfunction of the lower extremity due to neurological or internal diseases such as stroke, traumatic brain injury, and diabetic foot disease
Severe knee joint effusion
BM I> 35
Acute exacerbation of knee pain (less than 1 month)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity based on the Visual Analogue Scale. Timepoint: Measuring pain intensity before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Symptoms. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Pain. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Function, daily living. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Function, sports and recreational activities. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Quality of Life. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).