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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171987
Recruitment Status : Unknown
Verified March 2020 by Meng-Huang Wu, Taipei Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : May 31, 2017
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Meng-Huang Wu, Taipei Medical University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Back Pain Drug: Lidocaine patch local application Drug: Flurbiprofen patch local application Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  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.
Masking: Double (Care Provider, Investigator)
Masking Description: The investigator and care provider will be blind to group. Participant will know their treatment.
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine patch
Lidocaine patch local application 1 piece per day for 28 days at back pain area.
 Drug: Lidocaine patch local application
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
Other Name: Lidopat patch
Active Comparator: Flurbiprofen patch
Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.
 Drug: Flurbiprofen patch local application
Attach the patch to back pain area 1 piece per day with no more than 6 hours.


Outcome Measures
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Primary Outcome Measures :
  1. Numeric rating scale (NRS) [ Time Frame: 28 day ]
    Back pain relief effectiveness


Secondary Outcome Measures :
  1. Numeric rating scale (NRS) [ Time Frame: 0, 1, 3, 7, 14, 21 day ]
    Back pain relief effectiveness

  2. Brief Pain Inventory-Quality of Life (BPI-QoL) [ Time Frame: 0, 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  3. Oswestry Disability Questionnaire (ODQ) [ Time Frame: 0, 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  4. Core Outcome Measurement Index (COMI) [ Time Frame: 0, 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  5. EQ5D Quality of Life questionnaires Efficacy [ Time Frame: 0, 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  6. Short form-Mcgill Pain Questionnaire (SF-MPQ-2) [ Time Frame: 0, 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  7. Overall Treatment Effect Scale (OTE) [ Time Frame: 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  8. Analgesic consumption [ Time Frame: 7, 14, 21, 28 day ]
    Back pain relief effectiveness

  9. Skin reaction grade (Assessment of dermal response) [ Time Frame: 1, 3, 7, 14, 21, 28 days ]
    Safety

  10. Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 1, 3, 7, 14, 21, 28 days ]
    Safety


Other Outcome Measures:
  1. Physical exams for back range of motion [ Time Frame: 0, 7, 14, 21, 28 day ]
    Back pain relief effectiveness


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171987


Contacts
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Contact: Meng-Huang Wu, MD +886227372181 ext 3740 maxwutmu@gmail.com

Locations
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Taiwan
Postal Hospital Recruiting
Taipei, Taiwan, 11031
Contact: JEN-YUH CHEN, MD    +8862395-6755    bonechen2010@gmail.com   
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Meng-Huang Wu, MD    +886227372181 ext 3740    maxwutmu@gmail.com   
Principal Investigator: Meng-Huang Wu, MD         
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
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Study Chair: Ray-Jade Chen, MD Taipei Medical University Hospital
More Information
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Publications:

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Responsible Party: Meng-Huang Wu, Orthopedic specialist, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03171987    
Other Study ID Numbers: N201702048
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No shore IPD plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Meng-Huang Wu, Taipei Medical University Hospital:
lidocaine patch
flurbiprofen patch
acute back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Flurbiprofen
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
 Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors