NCT03171987

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-06-14
• Primary completion: 2021-03-31
• Completion: 2021-06-30
• First posted: 2017-05-31
• Last updated: 2024-04-10

Locations

2 sites across 1 country: Taiwan