Clinical trial NCT03171987: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Back Pain
Keywords: lidocaine patch
flurbiprofen patch
acute back pain
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: 28 day
Secondary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: 0, 1, 3, 7, 14, 21 day
measure: Brief Pain Inventory-Quality of Life (BPI-QoL)
timeFrame: 0, 7, 14, 21, 28 day
measure: Oswestry Disability Questionnaire (ODQ)
timeFrame: 0, 7, 14, 21, 28 day
measure: Core Outcome Measurement Index (COMI)
timeFrame: 0, 7, 14, 21, 28 day
measure: EQ5D Quality of Life questionnaires Efficacy
timeFrame: 0, 7, 14, 21, 28 day
measure: Short form-Mcgill Pain Questionnaire (SF-MPQ-2)
timeFrame: 0, 7, 14, 21, 28 day
measure: Overall Treatment Effect Scale (OTE)
timeFrame: 7, 14, 21, 28 day
measure: Analgesic consumption
timeFrame: 7, 14, 21, 28 day
measure: Skin reaction grade (Assessment of dermal response)
timeFrame: 1, 3, 7, 14, 21, 28 days
measure: Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: 1, 3, 7, 14, 21, 28 days
Other outcomes:
measure: Physical exams for back range of motion
timeFrame: 0, 7, 14, 21, 28 day
Locations:
city: Taipei
country: Taiwan
facility: Postal Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Ray-Jade Chen, MD
role: STUDY_CHAIR
References:
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.
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.
citation: Bolten W. The pharmacokinetics, pharmacodynamics and comparative efficacy of flurbiprofen LAT. Br J Clin Pract. 1994 Jul-Aug;48(4):190-5.