Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

Sponsor

H. Evren Eker (Other)

Overall Status

Completed

CT.gov ID

NCT02632565

Collaborator

Baskent University (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: Lidocaine Drug: Saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intra-articular 0.5% lidocaine intra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals	Drug: Lidocaine
Active Comparator: intra-articular saline intra-articular 7 mL saline injection for 3 times with one week intervals	Drug: Saline

Arm

Intervention/Treatment

Active Comparator: intra-articular 0.5% lidocaine

intra-articular 7 mL 0.5% lidocaine injection for 3 times with one week intervals

Drug: Lidocaine

Active Comparator: intra-articular saline

intra-articular 7 mL saline injection for 3 times with one week intervals

Drug: Saline

Outcome Measures

Primary Outcome Measures

Pain scores according to visual analog scale [3 months after the treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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