Acute Back Pain Clinical Trial
Official title:
The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
Verified date | March 2021 |
Source | Taipei Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | June 30, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Postal Hospital | Taipei | |
Taiwan | Taipei Medical University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University Hospital |
Taiwan,
Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical exams for back range of motion | Back pain relief effectiveness | 0, 7, 14, 21, 28 day | |
Primary | Numeric rating scale (NRS) | Back pain relief effectiveness | 28 day | |
Secondary | Numeric rating scale (NRS) | Back pain relief effectiveness | 0, 1, 3, 7, 14, 21 day | |
Secondary | Brief Pain Inventory-Quality of Life (BPI-QoL) | Back pain relief effectiveness | 0, 7, 14, 21, 28 day | |
Secondary | Oswestry Disability Questionnaire (ODQ) | Back pain relief effectiveness | 0, 7, 14, 21, 28 day | |
Secondary | Core Outcome Measurement Index (COMI) | Back pain relief effectiveness | 0, 7, 14, 21, 28 day | |
Secondary | EQ5D Quality of Life questionnaires Efficacy | Back pain relief effectiveness | 0, 7, 14, 21, 28 day | |
Secondary | Short form-Mcgill Pain Questionnaire (SF-MPQ-2) | Back pain relief effectiveness | 0, 7, 14, 21, 28 day | |
Secondary | Overall Treatment Effect Scale (OTE) | Back pain relief effectiveness | 7, 14, 21, 28 day | |
Secondary | Analgesic consumption | Back pain relief effectiveness | 7, 14, 21, 28 day | |
Secondary | Skin reaction grade (Assessment of dermal response) | Safety | 1, 3, 7, 14, 21, 28 days | |
Secondary | Common Terminology Criteria for Adverse Events (CTCAE) | Safety | 1, 3, 7, 14, 21, 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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