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

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.

Study Overview

• Status: Completed
• Conditions: Acute Back Pain
• Intervention / Treatment: Drug: Lidocaine patch local application; Drug: Flurbiprofen patch local application

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Meng-Huang Wu, MD; Phone Number: 3740 +886227372181; Email: maxwutmu@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 11031
    • Postal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All subjects underwent a detailed history and systemic physical examination including neurologic and musculoskeletal evaluations. To rule out any confounding etiologies, basic diagnostic laboratory tests including complete blood count and acute phase reactants (erythrocyte sedimentation rate and C-reactive protein) were performed. The patients diagnosed as having acute non-specific low back pain according to history and physical examinations were invited to participate and will be informed about the purpose and course of the study.

Main inclusion criteria

• A primary complaint of pain in the area between the 12th rib and buttock crease without 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine patch; Lidocaine patch local application 1 piece per day for 28 days at back pain area.	Drug: Lidocaine patch local application; Attach the patch to back pain area 1 piece per day with no more than 6 hours.; Other Names: Lidopat patch
Active Comparator: Flurbiprofen patch; Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.	Drug: Flurbiprofen patch local application; Attach the patch to back pain area 1 piece per day with no more than 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale (NRS)	Back pain relief effectiveness	28 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale (NRS)	Back pain relief effectiveness	0, 1, 3, 7, 14, 21 day
Brief Pain Inventory-Quality of Life (BPI-QoL)	Back pain relief effectiveness	0, 7, 14, 21, 28 day
Oswestry Disability Questionnaire (ODQ)	Back pain relief effectiveness	0, 7, 14, 21, 28 day
Core Outcome Measurement Index (COMI)	Back pain relief effectiveness	0, 7, 14, 21, 28 day
EQ5D Quality of Life questionnaires Efficacy	Back pain relief effectiveness	0, 7, 14, 21, 28 day
Short form-Mcgill Pain Questionnaire (SF-MPQ-2)	Back pain relief effectiveness	0, 7, 14, 21, 28 day
Overall Treatment Effect Scale (OTE)	Back pain relief effectiveness	7, 14, 21, 28 day
Analgesic consumption	Back pain relief effectiveness	7, 14, 21, 28 day
Skin reaction grade (Assessment of dermal response)	Safety	1, 3, 7, 14, 21, 28 days
Common Terminology Criteria for Adverse Events (CTCAE)	Safety	1, 3, 7, 14, 21, 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical exams for back range of motion	Back pain relief effectiveness	0, 7, 14, 21, 28 day

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Study Chair: Ray-Jade Chen, MD, Taipei Medical University Hospital

Publications and helpful links

General Publications

• Coste J, Lefrancois G, Guillemin F, Pouchot J; French Study Group for Quality of Life in Rheumatology. Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study. Arthritis Rheum. 2004 Apr 15;51(2):168-76. doi: 10.1002/art.20235.
• Mick G, Correa-Illanes G. Topical pain management with the 5% lidocaine medicated plaster--a review. Curr Med Res Opin. 2012 Jun;28(6):937-51. doi: 10.1185/03007995.2012.690339. Epub 2012 May 24.
• Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 27, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: lidocaine patch; flurbiprofen patch; acute back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Flurbiprofen
• Other Study ID Numbers: N201702048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No shore IPD plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No