The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
Overview
- Phase
- Phase 4
- Intervention
- Lidocaine patch local application
- Conditions
- Acute Back Pain
- Sponsor
- Taipei Medical University Hospital
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- Numeric rating scale (NRS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Meng-Huang Wu
Orthopedic specialist
Taipei Medical University Hospital
Eligibility Criteria
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
Arms & Interventions
Lidocaine patch
Lidocaine patch local application 1 piece per day for 28 days at back pain area.
Intervention: Lidocaine patch local application
Flurbiprofen patch
Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.
Intervention: Flurbiprofen patch local application
Outcomes
Primary Outcomes
Numeric rating scale (NRS)
Time Frame: 28 day
Back pain relief effectiveness
Secondary Outcomes
- Core Outcome Measurement Index (COMI)(0, 7, 14, 21, 28 day)
- Numeric rating scale (NRS)(0, 1, 3, 7, 14, 21 day)
- Oswestry Disability Questionnaire (ODQ)(0, 7, 14, 21, 28 day)
- Brief Pain Inventory-Quality of Life (BPI-QoL)(0, 7, 14, 21, 28 day)
- EQ5D Quality of Life questionnaires Efficacy(0, 7, 14, 21, 28 day)
- Short form-Mcgill Pain Questionnaire (SF-MPQ-2)(0, 7, 14, 21, 28 day)
- Overall Treatment Effect Scale (OTE)(7, 14, 21, 28 day)
- Analgesic consumption(7, 14, 21, 28 day)
- Common Terminology Criteria for Adverse Events (CTCAE)(1, 3, 7, 14, 21, 28 days)
- Skin reaction grade (Assessment of dermal response)(1, 3, 7, 14, 21, 28 days)