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

Taipei Medical University

Status and phase: Completed; Phase 4

Conditions: Acute Back Pain

Treatments: Drug: Lidocaine patch local application; Drug: Flurbiprofen patch local application

Study type: Interventional

Funder types: Other

Identifiers

NCT03171987

N201702048

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 2 patient groups

Lidocaine patch

Experimental group

Description:

Lidocaine patch local application 1 piece per day for 28 days at back pain area.

Treatment:

Drug: Lidocaine patch local application

Flurbiprofen patch

Active Comparator group

Description:

Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.

Treatment:

Drug: Flurbiprofen patch local application