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

NCT ID: NCT03171987

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2021-06-30

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.

Conditions

Acute Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine patch

Lidocaine patch local application 1 piece per day for 28 days at back pain area.

Group Type: EXPERIMENTAL

Lidocaine patch local application

Intervention Type: DRUG

Attach the patch to back pain area 1 piece per day with no more than 6 hours.

Flurbiprofen patch

Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.

Group Type: ACTIVE_COMPARATOR

Flurbiprofen patch local application

Intervention Type: DRUG

Attach the patch to back pain area 1 piece per day with no more than 6 hours.

Interventions

Lidocaine patch local application

Attach the patch to back pain area 1 piece per day with no more than 6 hours.

Intervention Type: DRUG

Flurbiprofen patch local application

Attach the patch to back pain area 1 piece per day with no more than 6 hours.

Intervention Type: DRUG

Other Intervention Names

Lidopat patch

Eligibility Criteria

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.

• 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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Meng-Huang Wu

Orthopedic specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ray-Jade Chen, MD

Role: STUDY_CHAIR

Taipei Medical University Hospital

Locations

Postal Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 15077256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22551228 (View on PubMed)

Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5.

Reference Type: BACKGROUND

PMID: 7917798 (View on PubMed)

Other Identifiers

N201702048

Identifier Type: -

Identifier Source: org_study_id