Skip to main content
OpenTrials
Completed

NCT Number: NCT03171987

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Back Pain

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Postal Hospital, Taipei, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine patch local application

Drug

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

Other names: Lidopat patch

Flurbiprofen patch local application

Drug

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

Primary outcomes

  1. Numeric rating scale (NRS)

    Time frame: 28 day

    Back pain relief effectiveness

Secondary outcomes

  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 outcomes

  1. Physical exams for back range of motion

    Time frame: 0, 7, 14, 21, 28 day

    Back pain relief effectiveness

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 31, 2017
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.