Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

Phase 4

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Saline; Drug: Lidocaine

• Registration Number: NCT02632565
• Lead Sponsor: H. Evren Eker

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2015-03
• Study Completion: 2015-08
• Status Verified: 2015-12
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Study First Posted: 2015-12-16
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee
• pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee OA

Exclusion Criteria

• the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intra-articular saline	Saline	intra-articular 7 mL saline injection for 3 times with one week intervals
intra-articular 0.5% lidocaine	Lidocaine	intra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals

Primary Outcome Measures

Name	Time	Method
Pain scores according to visual analog scale	3 months after the treatment