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

Last updated: April 9, 2024
Sponsor: Taipei Medical University Hospital
Overall Status: Completed

Phase

4

Condition

Chronic Pain

Treatment

Lidocaine patch local application

Flurbiprofen patch local application

Clinical Study ID

NCT03171987
N201702048
  • Ages 20-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All subjects underwent a detailed history and systemic physical examination includingneurologic and musculoskeletal evaluations. To rule out any confounding etiologies,basic diagnostic laboratory tests including complete blood count and acute phasereactants (erythrocyte sedimentation rate and C-reactive protein) were performed. Thepatients diagnosed as having acute non-specific low back pain according to history andphysical examinations were invited to participate and will be informed about thepurpose and course of the study. Main inclusion criteria
  • A primary complaint of pain in the area between the 12th rib and buttock creasewithout leg pain
  • Female or male, 20 - 80 years of age
  • Low back pain of less than six weeks' duration; and at least moderate pain intensity (NRS≧4)

Exclusion

Exclusion Criteria: Main exclusion criteria:

  • Known or suspected serious spinal pathology and spinal implants
  • Lumbar spinal surgery within the preceding six months
  • Serious comorbidities preventing prescription of paracetamol
  • Alternative treatment for low back pain in previous two weeks
  • Chronic neurological lesion
  • Chronic musculoskeletal lesion
  • Active cancer
  • Pregnancy
  • Use of pain medication (except paracetamol) within 3 days
  • Treatment site has active skin lesion or inflammation
  • Known allergy to skin patch

Study Design

Total Participants: 85
Treatment Group(s): 2
Primary Treatment: Lidocaine patch local application
Phase: 4
Study Start date:
June 14, 2017
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Postal Hospital

    Taipei, 11031
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei, 110
    Taiwan

    Site Not Available

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