Acute Back InjuryNCT03905681
TENS Efficacy on Acute Back Pain in an Emergency Department Triage
A study testing Transcutaneous Electrical Nerve Stimulation in people with Acute Back Injury, run by William Beaumont Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Back Injury
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 16 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Army Medical Center
Fort Bliss, Texas, 79920
About this study
Official title: The Use of Transcutaneous Electrical Nerve Stimulation on the Efficacy of Acute Back Pain Within an Emergency Department Triage: A Randomized Trial
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.
Read the 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.
- Conditions
- Acute Back Injury
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Acute back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS
Application of TENS pads and wearing of the TENS device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 30-minute duration of treatment
Secondary outcomes (1)
Increase in patient satisfaction while awaiting treatment
Using an assessment questionnaire of patient satisfaction, with nominal and ordinal results measured for statistical significance:
- Do you feel that early intervention with this device increases your satisfaction as a patient?
- If given the opportunity, would you like to continue to use this device while waiting?
- If you were to guess, do you think you were part of the treatment group or the no-treatment group?
- 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?
Measured: After 30-minute duration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start2 Apr 2019
- Primary completion16 May 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Back InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Beaumont Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David Manley, William Beaumont Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905681
- Sponsor's protocol ID
- C.2019.027d
- Status last verified
- May 2019
- First submitted
- 30 Mar 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25642029Sluka 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.
PubMed 14622708Brosseau 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.
PubMed 11884907Chandran 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.
PubMed 12620611Lauretti 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.
PubMed 25655828Ayyildiz 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.
PubMed 17162100Gozani 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.
PubMed 27418854
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcutaneous Electrical Nerve Stimulation on the Efficacy of Acute Back Pain Within an Emergency Department Triage: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03905681
- Acronym / sponsor ID
- C.2019.027d
- Conditions
- Acute Back Injury
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Acute back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- William Beaumont Army Medical CenterUS federal agency
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active TENS Group "Group A" | Active comparator | Device: Transcutaneous Electrical Nerve StimulationAfter 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. |
| Placebo TENS Group "Group B" | Placebo comparator | Device: Transcutaneous Electrical Nerve StimulationAfter 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENSApplication of TENS pads and wearing of the TENS device. | Device | Active TENS Group "Group A", Placebo TENS Group "Group B" |
Primary outcome
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.
1 secondary outcome
Increase in patient satisfaction while awaiting treatment
Time frame: After 30-minute duration of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 25642029Bi 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.
- Background: PubMed 14622708Sluka 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.
- Background: PubMed 11884907Brosseau 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.
- Background: PubMed 12620611Chandran 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.
- Background: PubMed 25655828Lauretti 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.
- Background: PubMed 17162100Ayyildiz 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.
- Background: PubMed 27418854Gozani 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Acute Back Injury, run by William Beaumont Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in pain using Visual Analogue Scores (VAS) (time frame: After 30-minute duration of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905681, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.