NCT Number: NCT02632565
Intra-Articular 0.5 % Lidocaine Injection for 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.
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Notify MeKey information
Conditions
Age range
50 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Saline
DrugPrimary outcomes
-
Pain scores according to visual analog scale
Time frame: 3 months after the treatment
Sponsors and collaborators
Lead sponsor
H. Evren Eker
Other
Collaborators
- Baskent University
Registry information
Official study title
Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis
Important dates
- Study start
- 2009
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 16, 2015
- Registry last updated
- Dec 16, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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