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

Primary Purpose

Acute Back Pain

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Lidocaine patch local application
Flurbiprofen patch local application
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Back Pain focused on measuring lidocaine patch, flurbiprofen patch, acute back pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postal HospitalRecruiting
  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lidocaine patch

Flurbiprofen patch

Arm Description

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

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

Outcomes

Primary Outcome Measures

Numeric rating scale (NRS)
Back pain relief effectiveness

Secondary Outcome Measures

Numeric rating scale (NRS)
Back pain relief effectiveness
Brief Pain Inventory-Quality of Life (BPI-QoL)
Back pain relief effectiveness
Oswestry Disability Questionnaire (ODQ)
Back pain relief effectiveness
Core Outcome Measurement Index (COMI)
Back pain relief effectiveness
EQ5D Quality of Life questionnaires Efficacy
Back pain relief effectiveness
Short form-Mcgill Pain Questionnaire (SF-MPQ-2)
Back pain relief effectiveness
Overall Treatment Effect Scale (OTE)
Back pain relief effectiveness
Analgesic consumption
Back pain relief effectiveness
Skin reaction grade (Assessment of dermal response)
Safety
Common Terminology Criteria for Adverse Events (CTCAE)
Safety

Full Information

First Posted
May 24, 2017
Last Updated
March 10, 2020
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03171987
Brief Title
The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
Official Title
The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Back Pain
Keywords
lidocaine patch, flurbiprofen patch, acute back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Lidocaine patch group: 1 piece lidocaine patch per day at back pain area. The treatment lasts for 28 days. Flurbiprofen patch group: 1 piece flurbiprofen patch per day at back pain area. The treatment lasts for 28 days.
Masking
Care ProviderInvestigator
Masking Description
The investigator and care provider will be blind to group. Participant will know their treatment.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine patch
Arm Type
Experimental
Arm Description
Lidocaine patch local application 1 piece per day for 28 days at back pain area.
Arm Title
Flurbiprofen patch
Arm Type
Active Comparator
Arm Description
Flurbiprofen patch local application 1 piece per day for 28 days at back pain area.
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch local application
Other Intervention Name(s)
Lidopat patch
Intervention Description
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen patch local application
Intervention Description
Attach the patch to back pain area 1 piece per day with no more than 6 hours.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS)
Description
Back pain relief effectiveness
Time Frame
28 day
Secondary Outcome Measure Information:
Title
Numeric rating scale (NRS)
Description
Back pain relief effectiveness
Time Frame
0, 1, 3, 7, 14, 21 day
Title
Brief Pain Inventory-Quality of Life (BPI-QoL)
Description
Back pain relief effectiveness
Time Frame
0, 7, 14, 21, 28 day
Title
Oswestry Disability Questionnaire (ODQ)
Description
Back pain relief effectiveness
Time Frame
0, 7, 14, 21, 28 day
Title
Core Outcome Measurement Index (COMI)
Description
Back pain relief effectiveness
Time Frame
0, 7, 14, 21, 28 day
Title
EQ5D Quality of Life questionnaires Efficacy
Description
Back pain relief effectiveness
Time Frame
0, 7, 14, 21, 28 day
Title
Short form-Mcgill Pain Questionnaire (SF-MPQ-2)
Description
Back pain relief effectiveness
Time Frame
0, 7, 14, 21, 28 day
Title
Overall Treatment Effect Scale (OTE)
Description
Back pain relief effectiveness
Time Frame
7, 14, 21, 28 day
Title
Analgesic consumption
Description
Back pain relief effectiveness
Time Frame
7, 14, 21, 28 day
Title
Skin reaction grade (Assessment of dermal response)
Description
Safety
Time Frame
1, 3, 7, 14, 21, 28 days
Title
Common Terminology Criteria for Adverse Events (CTCAE)
Description
Safety
Time Frame
1, 3, 7, 14, 21, 28 days
Other Pre-specified Outcome Measures:
Title
Physical exams for back range of motion
Description
Back pain relief effectiveness
Time Frame
0, 7, 14, 21, 28 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meng-Huang Wu, MD
Phone
+886227372181
Ext
3740
Email
maxwutmu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Jade Chen, MD
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Postal Hospital
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEN-YUH CHEN, MD
Phone
+8862395-6755
Email
bonechen2010@gmail.com
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng-Huang Wu, MD
Phone
+886227372181
Ext
3740
Email
maxwutmu@gmail.com
First Name & Middle Initial & Last Name & Degree
Meng-Huang Wu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No shore IPD plan.
Citations:
PubMed Identifier
15077256
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.
Results Reference
background
PubMed Identifier
22551228
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.
Results Reference
background
PubMed Identifier
7917798
Citation
Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5.
Results Reference
background

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

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