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TENS Efficacy on Acute Back Pain in an Emergency Department Triage

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ClinicalTrials.gov Identifier: NCT03905681
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
David Manley, William Beaumont Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Back Injury Device: Transcutaneous Electrical Nerve Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Masking Description: After computer-generated randomization, participants will either receive the active TENS treatment for 30 minutes, or receive the application of TENS pads and wear the device with no electrical stimulation. Both groups will have pre and post visual analogue scores assessed.
Primary Purpose: Treatment
Official Title: The Use of Transcutaneous Electrical Nerve Stimulation on the Efficacy of Acute Back Pain Within an Emergency Department Triage: A Randomized Trial
Actual Study Start Date : April 2, 2019
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : May 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active TENS Group "Group A"
After all necessary data collection forms are obtained, a pre-VAS score will be obtained. The participant will point to the area of maximum subjective pain, and then four TENS pads will be applied directly around the point of maximal pain that was determined by the patient, located at least 3 centimeters but no more than 6 centimeters from the area in a square or frame-like placement. While the device is off, it will be set at the following settings: The selector switch will be set to 'Milli' or milliamperes, and the frequency dial will be rotated to 100 Hertz. The participant will be instructed to rotate both dials in a clockwise direction if more intensity is desired, or counter-clockwise if less intensity is desired. The participant will wear the device and pads for a 30-minute duration; upon completion, post-VAS scores and a patient satisfaction survey will be obtained.
Device: Transcutaneous Electrical Nerve Stimulation
Application of TENS pads and wearing of the TENS device.
Other Name: TENS

Placebo Comparator: Placebo TENS Group "Group B"
After all necessary data collection forms are obtained, a pre-VAS score will be obtained. The participant will point to the area of maximum subjective pain, and then four TENS pads will be applied directly around the point of maximal pain that was determined by the patient, located at least 3 centimeters but no more than 6 centimeters from the area in a square or frame-like placement. However, no electrical stimulation will be provided. The participant will also wear the device and pads for a 30-minute duration; upon completion, post-VAS scores and a patient satisfaction survey will be obtained.
Device: Transcutaneous Electrical Nerve Stimulation
Application of TENS pads and wearing of the TENS device.
Other Name: TENS




Primary Outcome Measures :
  1. Decrease in pain using Visual Analogue Scores (VAS) [ Time Frame: After 30-minute duration of treatment ]
    Enrolled participants will have baseline Visual Analogue Scores (VAS) pain scale scores assessed, consisting of a 0 to 100 unit scale, with instruction to locate their level of pain on the scale of 0 being "No pain at all," 50 being "Moderate Pain," and 100 being "Worst pain imaginable," and will be compared to score on the same scale after treatment.


Secondary Outcome Measures :
  1. Increase in patient satisfaction while awaiting treatment [ Time Frame: After 30-minute duration of treatment ]

    Using an assessment questionnaire of patient satisfaction, with nominal and ordinal results measured for statistical significance:

    1. Do you feel that early intervention with this device increases your satisfaction as a patient?
    2. If given the opportunity, would you like to continue to use this device while waiting?
    3. If you were to guess, do you think you were part of the treatment group or the no-treatment group?
    4. On a scale of 1 through 10, with 1 being "completely dissatisfied" and 10 being "completely satisfied," how satisfied are you with being provided this treatment?



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905681


Locations
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United States, Texas
William Beaumont Army Medical Center
Fort Bliss, Texas, United States, 79920
Sponsors and Collaborators
William Beaumont Army Medical Center
Publications:

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Responsible Party: David Manley, Captain David Manley, PA-C, Emergency Medicine Physician Assistant Resident, William Beaumont Army Medical Center
ClinicalTrials.gov Identifier: NCT03905681    
Other Study ID Numbers: C.2019.027d
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once the study is completed, the data used for statistical analysis will be void of personally identifiable information. This data will be in electronic form for use in government-approved software, such as Microsoft Office. These documents will be distributed only to the Primary Investigator and the William Beaumont Army Medical Center (WBAMC) Department of Clinical Investigations assistance with statistical analysis or future publishing consideration. All paper documents are to be maintained in accordance with Department of Clinical Investigations policies; study-specific electronic documents will be kept for a minimum of 3 years before deletion. Upon study closure, all personally identifiable information (including the Master Key) will be destroyed or deleted, and a de-identified data set maintained by the WBAMC Emergency Medicine Physician Assistant Residency Program Director for further study as needed. No human biological specimens will be maintained.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 3 years, or as determined by the WBAMC Department of Clinical Investigations.
Access Criteria: Principal Investigator, WBAMC Department of Clinical Investigations, WBAMC Emergency Medicine Physician Assistant Residency Program Director.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David Manley, William Beaumont Army Medical Center:
Transcutaneous Electrical Nerve Stimulation, Acute back pain
Additional relevant MeSH terms:
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Back Pain
Emergencies
Back Injuries
Pain
Neurologic Manifestations
Disease Attributes
Pathologic Processes
Wounds and Injuries