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

Phase 4

Completed

• Conditions: Acute Back Pain
• Interventions: Drug: Flurbiprofen patch local application; Drug: Lidocaine patch local application

• Registration Number: NCT03171987
• Lead Sponsor: Taipei Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-27
• Study First Posted: 2017-05-31
• Study Start: 2017-06-14
• Status Verified: 2021-03
• Primary Completion: 2021-03-31
• Study Completion: 2021-06-30
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS)	28 day	Back pain relief effectiveness

Secondary Outcome Measures

Name	Time	Method
Short form-Mcgill Pain Questionnaire (SF-MPQ-2)	0, 7, 14, 21, 28 day	Back pain relief effectiveness
Overall Treatment Effect Scale (OTE)	7, 14, 21, 28 day	Back pain relief effectiveness
Analgesic consumption	7, 14, 21, 28 day	Back pain relief effectiveness
Common Terminology Criteria for Adverse Events (CTCAE)	1, 3, 7, 14, 21, 28 days	Safety
Core Outcome Measurement Index (COMI)	0, 7, 14, 21, 28 day	Back pain relief effectiveness
Numeric rating scale (NRS)	0, 1, 3, 7, 14, 21 day	Back pain relief effectiveness
Oswestry Disability Questionnaire (ODQ)	0, 7, 14, 21, 28 day	Back pain relief effectiveness
Brief Pain Inventory-Quality of Life (BPI-QoL)	0, 7, 14, 21, 28 day	Back pain relief effectiveness
EQ5D Quality of Life questionnaires Efficacy	0, 7, 14, 21, 28 day	Back pain relief effectiveness
Skin reaction grade (Assessment of dermal response)	1, 3, 7, 14, 21, 28 days	Safety

Trial Locations

Locations (2)

Postal Hospital; 🇨🇳 Taipei, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan