Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632565
• Other study ID #: KA08/83
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2015
• Last updated: December 14, 2015
• Start date: December 2009
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

Intervention

Drug:
• Lidocaine

• Saline

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
H. Evren Eker	Baskent University

References & Publications (2)

Elhakim M, Nafie M, Eid A, Hassin M. Combination of intra-articular tenoxicam, lidocaine, and pethidine for outpatient knee arthroscopy. Acta Anaesthesiol Scand. 1999 Sep;43(8):803-8. — View Citation

Pietruck C, Grond S, Xie GX, Palmer PP. Local anesthetics differentially inhibit sympathetic neuron-mediated and C fiber-mediated synovial neurogenic plasma extravasation. Anesth Analg. 2003 May;96(5):1397-402, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores according to visual analog scale		3 months after the treatment	Yes