Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05601843

Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED)

Conditions: Back Pain, Muscle Pain, Acute Pain, Lower Back Pain, Lower Back Pain Mechanical

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Sam Brophy

Summary

The effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) to reduce pain scores for patients with acute back pain in an ambulatory emergency department (ED) population will be examined in this dual-center, cluster randomized, controlled, open-label study.

Eligibility Criteria

Inclusion Criteria:Age 18 years or older.Acute or acute-on-chronic back pain, defined as less than 3 weeks of increased symptoms.Canadian Triage and Acuity Scale (CTAS) level 3-5 in ambulatory section of emergency department8.Projected wait-time of at least 30 minutes.Comfortable with communication in English. Unfortunately, currently, we do not have the capacity or funding to hire a translator to translate our study documents or communicate with potential study participants.Exclusion Criteria:Back pain "red flags" on initial history. These include:Patient reported fever.Recent direct blunt or penetrating trauma to the back, perceived by the patient to be the cause of acute pain or exacerbation of chronic pain.Bilateral radicular symptoms.Changes in ability to empty bladder or urinary incontinence since onset of back pain.Incontinence of stool.Saddle anesthesia.Intravenous drug use within the last 30 days.History of spinal cord injury.Epilepsy.Abnormal triage vital signs:Temperature greater than 38 CAbnormal blood pressure (BP) defined as systolic BP less than 90 or over 180.Tachypnea with respiratory rate (RR) greater than 22.Active pregnancy (patient warning on product label)Canadian Triage and Acuity Scale (CTAS) level 1-2.Implanted pacemaker or neurostimulation device.TENS unit in use by another patient at time of screeningWound, abrasion, rash over where TENS pads will be placed.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05601843). StuddyBuddy aggregates publicly available trial information.