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Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

Primary Purpose

Chronic Pain

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Lidocaine

Saline

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring osteoarthritis, lidocaine, pain, ultrasound

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

intra-articular 0.5% lidocaine

intra-articular saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain scores according to visual analog scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02632565

First Posted

December 3, 2015

Last Updated

December 14, 2015

Sponsor

H. Evren Eker

Collaborators

Baskent University

1. Study Identification

Unique Protocol Identification Number

NCT02632565

Brief Title

Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

H. Evren Eker

Collaborators

Baskent University

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

osteoarthritis, lidocaine, pain, ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intra-articular 0.5% lidocaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

intra-articular saline

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Type

Drug

Intervention Name(s)

Saline

Primary Outcome Measure Information:

Title

Pain scores according to visual analog scale

Time Frame

3 months after the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anis Aribogan, Prof

Organizational Affiliation

Coordinator

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10492407

Citation

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.

Results Reference

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PubMed Identifier

12707141

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

Results Reference

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Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis

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