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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171987
Other study ID # N201702048
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 14, 2017
Est. completion date June 30, 2021

Study information

Verified date March 2021
Source Taipei Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine patch local application
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
Flurbiprofen patch local application
Attach the patch to back pain area 1 piece per day with no more than 6 hours.

Locations

Country Name City State
Taiwan Postal Hospital Taipei
Taiwan Taipei Medical University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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

Outcome

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
See also
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