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The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain

NCT03171987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-04-10

No results posted yet for this study

Summary

This is a prospective, randomized, single blinded, two-arm, head to head study.

The purpose of this study is:

* To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for treatment of acute low back pain.

Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving functional disabilities and in reducing pain resulting from acute low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to 1-Months.

Conditions

  • Acute Back Pain

Interventions

DRUG

Lidocaine patch local application

Attach the patch to back pain area 1 piece per day with no more than 6 hours.

DRUG

Flurbiprofen patch local application

Attach the patch to back pain area 1 piece per day with no more than 6 hours.

Sponsors & Collaborators

  • Taipei Medical University Hospital

    lead OTHER

Principal Investigators

  • Ray-Jade Chen, MD · Taipei Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2021-03-31
Completion
2021-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171987 on ClinicalTrials.gov