Acute Back Pain
Conditions
Keywords
lidocaine patch, flurbiprofen patch, acute back pain
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.
Interventions
DRUGLidocaine patch local application
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
DRUGFlurbiprofen patch local application
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
Sponsors
Taipei Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The investigator and care provider will be blind to group. Participant will know their treatment.
Intervention model description
1. Lidocaine patch group: 1 piece lidocaine patch per day at back pain area. The treatment lasts for 28 days. 2. Flurbiprofen patch group: 1 piece flurbiprofen patch per day at back pain area. The treatment lasts for 28 days.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) | 28 day | Back pain relief effectiveness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin reaction grade (Assessment of dermal response) | 1, 3, 7, 14, 21, 28 days | Safety |
| Common Terminology Criteria for Adverse Events (CTCAE) | 1, 3, 7, 14, 21, 28 days | Safety |
| Numeric rating scale (NRS) | 0, 1, 3, 7, 14, 21 day | Back pain relief effectiveness |
| Brief Pain Inventory-Quality of Life (BPI-QoL) | 0, 7, 14, 21, 28 day | Back pain relief effectiveness |
| Analgesic consumption | 7, 14, 21, 28 day | Back pain relief effectiveness |
| Core Outcome Measurement Index (COMI) | 0, 7, 14, 21, 28 day | Back pain relief effectiveness |
| EQ5D Quality of Life questionnaires Efficacy | 0, 7, 14, 21, 28 day | Back pain relief effectiveness |
| Short form-Mcgill Pain Questionnaire (SF-MPQ-2) | 0, 7, 14, 21, 28 day | Back pain relief effectiveness |
| Overall Treatment Effect Scale (OTE) | 7, 14, 21, 28 day | Back pain relief effectiveness |
| Oswestry Disability Questionnaire (ODQ) | 0, 7, 14, 21, 28 day | Back pain relief effectiveness |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical exams for back range of motion | 0, 7, 14, 21, 28 day | Back pain relief effectiveness |
Countries
Taiwan
Outcome results
None listed