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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Back Pain

Intervention / Treatment
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* Drug: Lidocaine patch local application
* Drug: Flurbiprofen patch local application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Lidocaine patch group: 1 piece lidocaine patch per day at back pain area. The treatment lasts for 28 days. Flurbiprofen patch group: 1 piece flurbiprofen patch per day at back pain area. The treatment lasts for 28 days.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine patch, flurbiprofen patch, acute back pain