Chronic Pain Clinical Trial
Official title:
Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis
In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.
Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26)
received intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL
saline into painful knee for 3 times with one week intervals under USG guidance. VAS and
WOMAC scale including pain, stiffness and physical function was used for the assessment of
patients with osteoarthritis. Analgesic requirements were also recorded.
The primary outcome parameter of this study was the pain scores. The sample size for the
primary variable was calculated based on a standard deviation of 20 mm estimated from a
previous study. A power analysis with a type II error of 20% at a two-sided 5% significance
level estimated 22 patients per group to be included. Investigators included 26 patients per
groups for possible missing date. χ2 test for categorical data and independent samples
t-test for the comparison of VAS and WOMAC scores between groups were used for statistical
analysis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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