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This is a prospective, randomized, single blinded, two-arm, head to head study.
The purpose of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine patch | Experimental | Lidocaine patch local application 1 piece per day for 28 days at back pain area. |
|
| Flurbiprofen patch | Active Comparator | Flurbiprofen patch local application 1 piece per day for 28 days at back pain area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch local application | Drug | Attach the patch to back pain area 1 piece per day with no more than 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) | Back pain relief effectiveness | 28 day |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical exams for back range of motion | Back pain relief effectiveness | 0, 7, 14, 21, 28 day |
Inclusion Criteria:
Main inclusion criteria
Exclusion Criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ray-Jade Chen, MD | Taipei Medical University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postal Hospital | Taipei | 11031 | Taiwan | |||
| Taipei Medical University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15077256 | Background | 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. | |
| 22551228 | Background |
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No shore IPD plan.
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The investigator and care provider will be blind to group. Participant will know their treatment.
| Flurbiprofen patch local application | Drug | Attach the patch to back pain area 1 piece per day with no more than 6 hours. |
|
| 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 |
| Taipei |
| 110 |
| Taiwan |
| 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. |
| 7917798 | Background | Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5. |