NCT02632565

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 chronic-pain

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_4 chronic-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

5.2 years

First QC Date

December 3, 2015

Last Update Submit

December 14, 2015

Conditions

Keywords

osteoarthritislidocainepainultrasound

Outcome Measures

Primary Outcomes (1)

  • Pain scores according to visual analog scale

    3 months after the treatment

Study Arms (2)

intra-articular 0.5% lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

intra-articular saline

ACTIVE COMPARATOR

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

Drug: Saline

Interventions

intra-articular 0.5% lidocaine
SalineDRUG
intra-articular saline

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

    PMID: 10492407BACKGROUND
  • 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.

    PMID: 12707141BACKGROUND

MeSH Terms

Conditions

Chronic PainOsteoarthritisPain

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Anis Aribogan, Prof

    Coordinator

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass Prof

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 16, 2015

Study Start

December 1, 2009

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

December 16, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share