Clinical trial NCT03905681: TENS Efficacy on Acute Back Pain in an Emergency Department Triage
Official title: The Use of Transcutaneous Electrical Nerve Stimulation on the Efficacy of Acute Back Pain Within an Emergency Department Triage: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Back Injury
Keywords: Transcutaneous Electrical Nerve Stimulation, Acute back pain
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2019-04-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using a sample population in a military treatment facility emergency department, this prospective, randomized controlled trial utilized forty-six total participants evenly divided to both a active and placebo group, were used to determine the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) on acute back pain of ambulatory patients presenting for emergent care.
Primary purpose: TREATMENT

Brief summary: Transcutaneous Electrical Nerve Stimulation (TENS) devices produce a gentle electrical stimulation that when applied through pads applied directly to the skin, has a noticeable effect in reducing pain associated with various types of injuries and ailments. Several recent studies have shown efficacy when used for acute pain specific to primary dysmenorrhea, renal colic, lower-extremity pain, and pain associated with spinal cord injury, and was achieved without adverse effects. This study is intended to compare the effects of TENS units on acute back pain on ambulatory patients who are awaiting emergency medical treatment, to uncover if a statistically-significant analgesic effect is noted compared to a placebo device.

Detailed description: With the emerging amount of new data on the treatment specific to acute pain, it is theorized that early TENS application can be an adjunct for acute pain reduction, specifically for patients awaiting treatment in an emergency department triage waiting room. TENS stimulators are advantageous to patients in that they are non-pharmacologic and non-invasive therapy. TENS devices have an excellent safety profile, are associated with very few contraindications, and have negligible side-effects or adverse events: the most common being minor skin irritation. (Sluka and Walsh 2003) Of financial benefit to a hospital considering their implementation, these devices are also inexpensive. In the realm of emergency medicine, which is being scrutinized to reduce opioid prescriptions, measures must be taken to maximize the efficacy of alternative pain-relief adjuncts.

There are significant gaps in the literature which have depicted no significant benefits compared to physical therapy and other modalities. These studies had used variable treatments times and frequencies, which were not solidified in scientific research at the time of their results. The use of these stimulators has been extensively studied, and the evidence to support their use on various conditions has been inconclusive. Early meta-analyses and systematic reviews have noted the data are inconsistent to suggest a mean reduction of pain when assessed on chronic pain. (Brosseau et al. 2002) However, when applied extensively and at regular settings, TENS has shown the presence of tolerance to TENS when used chronically in as few as four days. (Chandran and Sluka, 2003) This study is intended to harness the newest research comparing the most-effective settings and durations of TENS units, and compare the effects of TENS units on acute back pain on ambulatory patients who are awaiting emergency medical treatment.

Eligibility criteria: Inclusion Criteria:

* Presents to the Emergency Department in an ambulatory status
* Has a complaint of traumatic back pain, acute or acute-on-chronic, which is 3 weeks or less in duration.
* Is designated to an Emergency Severity Index Category of 4 or 5.
* Patient must be unfamiliar with TENS use
* Projected wait time of greater than 30 minutes before a visit with an Emergency Department provider is anticipated based on triage category
* Not actively pregnant for female patients

Exclusion Criteria:

* Patient has a history of using TENS in the past
* Patient is actively pregnant
* History of narcotic use or abuse in the last 24 hours
* Patient has a cardiac pacemaker or a neurostimulation-implant device
* Patient is designated to an Emergency Severity Index Category of 1, 2, or 3
* Patient has an open wound, abrasion, skin rash, or tattoo \< 6 weeks old where pads will be placed
* Patient has a current history of Low Back Pain 'red flags' (Bilateral radicular symptoms, saddle anesthesia or paresthesia, bladder incontinence, or bowel incontinence) which require immediate attention.

Primary outcomes:
measure: Decrease in pain using Visual Analogue Scores (VAS)
timeFrame: After 30-minute duration of treatment
Secondary outcomes:
measure: Increase in patient satisfaction while awaiting treatment
timeFrame: After 30-minute duration of treatment
Other outcomes:
Locations:
city: Fort Bliss
country: United States
facility: William Beaumont Army Medical Center
state: Texas
Study officials:
References:
citation: Bi X, Lv H, Chen BL, Li X, Wang XQ. Effects of transcutaneous electrical nerve stimulation on pain in patients with spinal cord injury: a randomized controlled trial. J Phys Ther Sci. 2015 Jan;27(1):23-5. doi: 10.1589/jpts.27.23. Epub 2015 Jan 9.
citation: Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.
citation: Brosseau L, Milne S, Robinson V, Marchand S, Shea B, Wells G, Tugwell P. Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a meta-analysis. Spine (Phila Pa 1976). 2002 Mar 15;27(6):596-603. doi: 10.1097/00007632-200203150-00007.
citation: Chandran P, Sluka KA. Development of opioid tolerance with repeated transcutaneous electrical nerve stimulation administration. Pain. 2003 Mar;102(1-2):195-201. doi: 10.1016/s0304-3959(02)00381-0.
citation: Lauretti GR, Oliveira R, Parada F, Mattos AL. The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. Neuromodulation. 2015 Aug;18(6):522-6; discussion 522-7. doi: 10.1111/ner.12269. Epub 2015 Feb 5.
citation: Ayyildiz A, Akgul T, Nuhoglu B. Re: Transcutaneous electrical nerve stimulation: an effective treatment for pain caused by renal colic in emergency care. B. Mora, E. Giorni, M. Dobrovits, R. Barker, T. Lang, C. Gore and A. Kober, J Urol 2006; 175: 1737. J Urol. 2007 Jan;177(1):405. doi: 10.1016/j.juro.2006.09.013. No abstract available.
citation: Gozani SN. Fixed-site high-frequency transcutaneous electrical nerve stimulation for treatment of chronic low back and lower extremity pain. J Pain Res. 2016 Jun 28;9:469-79. doi: 10.2147/JPR.S111035. eCollection 2016.