TENS Treatment Plus Ibuprofen for the Treatment of Acute Back Pain in the ED
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Low Back Pain
In brief
Patients presenting to the ED with a chief complaint of acute low back pain and whom the providing physician feels symptomatic treatment is appropriate in the ED will be screened for inclusion in the study. The purpose of the study is to compare Transcutaneous Electrical Nerve Stimulation (TENS) as an adjunct to ibuprofen in the treatment of acute low back pain in the emergency department. Therefore, the aim of this prospective, randomized, double blind study is to evaluate the efficacy of ED administered TENS in acute low back pain patients during their ED visit.
Key facts
- Study ID
- NCT02611583
- Run by
- Albert Einstein Healthcare Network
- People needed
- 0
- Starts
- 2016-06-24
- Expected to finish
- 2016-06-24
- Last updated by the study team
- 2017-05-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 18 years to 65 years of age presenting to the emergency room with a primary complaint of low back pain.
- Patient is receiving 800mg dose of ibuprofen as part of their treatment regimen for back pain
- Back pain new in the last 48 hours
- Deemed by the treating physician to have musculoskeletal back pain, and no central/peripheral nervous system pathology as the cause of their pain.
You may not qualify if…
- Allergy to ibuprofen.
- Hypotension (MAP <65 or Systolic BP <100), fever, tachycardia
- Paresthesias, isolated motor weakness, or objective sensory deficit on physical exam
- Radicular symptoms
- Urinary incontinence or retention
- Bowel incontinence
- Unexplained weight loss of >15 lbs in the last 3 months.
- Multiple primary complaints in the ED.
- Received Analgesia other than Ibuprofen as part of their ED work up.
- Taken prescription strength pain medication within the last 12 hours for any condition.
- History of active malignancy, HIV, organ transplantation, active hemodialysis
- Currently pregnant
- Nursing home residents
- Currently in police custody
Where it is running
- Albert Einstein Healthcare Network — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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