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Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

NCT ID: NCT02632565

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Keywords

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osteoarthritis lidocaine pain ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intra-articular 0.5% lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

intra-articular saline

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

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Lidocaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role collaborator

H. Evren Eker

OTHER

Sponsor Role lead

Responsible Party

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H. Evren Eker

Ass Prof

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anis Aribogan, Prof

Role: STUDY_CHAIR

Coordinator

References

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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. doi: 10.1034/j.1399-6576.1999.430804.x.

Reference Type BACKGROUND
PMID: 10492407 (View on PubMed)

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):1397-1402. doi: 10.1213/01.ANE.0000060454.34258.D3.

Reference Type BACKGROUND
PMID: 12707141 (View on PubMed)

Other Identifiers

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KA08/83

Identifier Type: -

Identifier Source: org_study_id