TENS Efficacy on Acute Back Pain in an Emergency Department Triage

NCT03905681 | Completed FDA Device

• 1 other identifier: C.2019.027d
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Back Injury

Keywords

Transcutaneous Electrical Nerve Stimulation, Acute back pain

Outcome Measures

Primary Outcomes (1)

• Decrease in pain using Visual Analogue Scores (VAS)

  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.

  After 30-minute duration of treatment

Secondary Outcomes (1)

• Increase in patient satisfaction while awaiting treatment

  After 30-minute duration of treatment

Study Arms (2)

Active TENS Group "Group A"

ACTIVE COMPARATOR

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

Placebo TENS Group "Group B"

PLACEBO COMPARATOR

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

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

Application of TENS pads and wearing of the TENS device.

Also known as: TENS

Active TENS Group "Group A"; Placebo TENS Group "Group B"

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Beaumont Army Medical Center: lead

Study Sites (1)

William Beaumont Army Medical Center

Fort Bliss, Texas, 79920, United States

Location

Related Publications (7)

• 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.

  PMID: 25642029 BACKGROUND

• 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.

  PMID: 14622708 BACKGROUND

• 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.

  PMID: 11884907 BACKGROUND

• 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.

  PMID: 12620611 BACKGROUND

• 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.

  PMID: 25655828 BACKGROUND

• 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.

  PMID: 17162100 BACKGROUND

• 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.

  PMID: 27418854 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Captain David Manley, PA-C, Emergency Medicine Physician Assistant Resident

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 5, 2019
• Study Start: April 2, 2019
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, 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.

Locations

US (1)