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

NCT03171987 | Completed Phase 4

• 1 other identifier: N201702048
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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

Keywords

lidocaine patch; flurbiprofen patch; acute back pain

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS)

  Back pain relief effectiveness

  28 day

Secondary Outcomes (10)

• Numeric rating scale (NRS)

  0, 1, 3, 7, 14, 21 day

• Brief Pain Inventory-Quality of Life (BPI-QoL)

  0, 7, 14, 21, 28 day

• Oswestry Disability Questionnaire (ODQ)

  0, 7, 14, 21, 28 day

• Core Outcome Measurement Index (COMI)

  0, 7, 14, 21, 28 day

• EQ5D Quality of Life questionnaires Efficacy

  0, 7, 14, 21, 28 day

Other Outcomes (1)

• Physical exams for back range of motion

  0, 7, 14, 21, 28 day

Study Arms (2)

Lidocaine patch

EXPERIMENTAL

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

Drug: Lidocaine patch local application

Flurbiprofen patch

ACTIVE COMPARATOR

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

Drug: Flurbiprofen patch local application

Interventions

Lidocaine patch local application DRUG

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

Also known as: Lidopat patch

Lidocaine patch

Flurbiprofen patch local application DRUG

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

Flurbiprofen patch

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (2)

Postal Hospital

Taipei, 11031, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 15077256 BACKGROUND

• 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.

  PMID: 22551228 BACKGROUND

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

  PMID: 7917798 BACKGROUND

Study Officials

• Ray-Jade Chen, MD

  Taipei Medical University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigator and care provider will be blind to group. Participant will know their treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic specialist

Model Details: 1. Lidocaine patch group: 1 piece lidocaine patch per day at back pain area. The treatment lasts for 28 days. 2. Flurbiprofen patch group: 1 piece flurbiprofen patch per day at back pain area. The treatment lasts for 28 days.

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 31, 2017
• Study Start: June 14, 2017
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: April 10, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)