Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients

NCT03301766 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 17-510
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the Emergency Department. In addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.

Conditions

Low Back Pain

Keywords

lidocaine

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NRS)

  Patient description of pain on a scale of 0-10

  1 week

Secondary Outcomes (2)

• Roland-Morris-24 back pain disability scale

  1 week and 1 month

• Numerical Pain Rating Scale (NRS)

  1 month

Other Outcomes (1)

• Repeat visits

  1 week and 1 month

Study Arms (2)

Lidocaine 5% patch

EXPERIMENTAL

Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.

Drug: lidocaine 5% patch; Drug: standard therapy

Non-medicated patch

ACTIVE COMPARATOR

Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.

Drug: standard therapy; Drug: Non-medicated patch

Interventions

lidocaine 5% patch DRUG

transdermal patch

Lidocaine 5% patch

standard therapy DRUG

Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)

Lidocaine 5% patch; Non-medicated patch

Non-medicated patch DRUG

non-medicated patch

Non-medicated patch

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pain originating between the lower border of the scapulae and the upper gluteal folds
• treating ED physician plan for discharge of the patient

You may not qualify if:

• radicular pain defined as pain radiating below the gluteal folds
• direct trauma to the back within previous month
• pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the past 3 months
• patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls
• known allergy to lidocaine or skin breakdown over site of pain
• treating physician plan for opioid prescription (tramadol, codeine, hydrocodone)
• personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery
• patients who are detainees
• previous enrollment in the study

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Lidocaine; Transdermal Patch; Standard of Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Emergency Medicine, Principal Investigator

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: March 10, 2017
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)