The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain

Acute Back Pain Clinical Trial

Official title:

The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171987
• Other study ID #: N201702048
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Back Pain
• Back Pain
• Low Back Pain

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