Back to resultsTranscutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED) (TENS-ED)
Primary Purpose
Back Pain, Muscle Pain, Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring Back pain, Mechanical back pain, Lower back pain, TENS, Transcutaneous Electrical Nerve Stimulation, Emergency, Emergency Department, Acute pain
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. Acute or acute-on-chronic back pain, defined as less than 3 weeks of increased symptoms. Canadian Triage and Acuity Scale (CTAS) level 3-5 in ambulatory section of emergency department8. Projected wait-time of at least 30 minutes. Comfortable with communication in English. Unfortunately, currently, we do not have the capacity or funding to hire a translator to translate our study documents or communicate with potential study participants. Exclusion Criteria: Back pain "red flags" on initial history. These include: Patient reported fever. Recent direct blunt or penetrating trauma to the back, perceived by the patient to be the cause of acute pain or exacerbation of chronic pain. Bilateral radicular symptoms. Changes in ability to empty bladder or urinary incontinence since onset of back pain. Incontinence of stool. Saddle anesthesia. Intravenous drug use within the last 30 days. History of spinal cord injury. Epilepsy. Abnormal triage vital signs: Temperature greater than 38 C Abnormal blood pressure (BP) defined as systolic BP less than 90 or over 180. Tachypnea with respiratory rate (RR) greater than 22. Active pregnancy (patient warning on product label) Canadian Triage and Acuity Scale (CTAS) level 1-2. Implanted pacemaker or neurostimulation device. TENS unit in use by another patient at time of screening Wound, abrasion, rash over where TENS pads will be placed.
Sites / Locations
- Royal Jubilee Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TENS Arm
Control Arm
Arm Description
Participants randomized to receive treatment with TENS in addition to standard care.
Participants randomized to not receive treatment with TENS. These participants receive standard care only.
Outcomes
Primary Outcome Measures
Pain Score Difference
Pain score as a primary outcome will be assessed by determining the difference in VAS between T0 and T60. VAS is a validated tool for measuring subject reports of pain in a variety of patient care settings. T60 was chosen as the primary endpoint as this was thought to allow sufficient time for standard care (ie. pharmacotherapy) to take effect. A clinically significant reduction of pain was defined as 30% on VAS, based on prior literature.
Secondary Outcome Measures
Pain score at T30
As a secondary outcome, pain score reduction at T30 will be assessed. This is to determine how effective TENS is at reduction pain immediately when finishing treatment. Similarly, a 30% reduction of pain score is considered clinically significant. No further assessment points will be used due to the variability of wait-times and high likelihood of loss to follow-up with later assessment points. We currently do not have capacity for telephone follow-up the next day.
Opioid requirements
A further secondary outcome is opioid requirements while in the ED, calculated by Oral Morphine Equivalents (OMEs). The duration of 8 hours or at time of discharge was determined to be an adequate length of time to allow for appropriate up-titration of opioids to achieve adequate pain treatment. Other forms of analgesia (ie. NSAIDs and acetaminophen) will not be tallied, due to the challenge of reliably interpreting the data - most patients have taken some form of over-the-counter analgesia prior to their ED encounter and different NSAIDs are often used without a reliable way of determining comparable such as OMEs for opioids.
ED Return Visits
Return visits to the ED within 2 weeks will also be compared between groups, specifically analyzing the proportion of repeat presentations with a triage complaint of "back pain." This will be done by accessing the EMR of each patient in the trial through by the PI or CIs. Presentations to all EDs in the Island Health region are available upon accessing our local EMR (PowerChart). No further details other than initial triage complaint will be collected on these repeat visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05601843
Brief Title
Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED)
Acronym
TENS-ED
Official Title
Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Low Back Pain in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
May 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sam Brophy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) to reduce pain scores for patients with acute back pain in an ambulatory emergency department (ED) population will be examined in this dual-center, cluster randomized, controlled, open-label study.
Detailed Description
Back pain is one of the top 5 most common ED presenting complaints, accounting for approximately 3% of all ED visits. It is estimated that 85% of these patients will leave the ED with a non-specific diagnosis, such as mechanical low back pain, and will recover within 4-6 weeks. Unfortunately, treatment for these patients is limited and often consists of NSAIDs, acetaminophen, and opioids if in significant pain.
TENS is a non-pharmacological option for the treatment of pain. The mechanism of its effect is based on the gate control theory of pain; stimulation of large, myelinated fibers reduces transmission of pain through smaller, nociceptive C-fibers through inhibitory actions of interneurons. It is very safe, with very few reported adverse effects and a short list of contraindications.
In 2015, a Cochrane review examined the benefit of TENS in acute pain, which was defined as less than 12 weeks. Their review demonstrated tentative evidence of benefit in reducing pain, although due to the small sample sizes of the encompassing trials and the inability to blind, definitive conclusions are impossible.
Research question: "In patients in the ED triage area,18 years of age or older with acute or acute-on-chronic back pain for less than three weeks, does 30 min of transcutaneous electrical nerve stimulation reduce pain scores as compared to standard care alone?"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Muscle Pain, Acute Pain, Lower Back Pain, Lower Back Pain Mechanical
Keywords
Back pain, Mechanical back pain, Lower back pain, TENS, Transcutaneous Electrical Nerve Stimulation, Emergency, Emergency Department, Acute pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS Arm
Arm Type
Experimental
Arm Description
Participants randomized to receive treatment with TENS in addition to standard care.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants randomized to not receive treatment with TENS. These participants receive standard care only.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Other Intervention Name(s)
Impulse® 3000 T (© 2014 BioMedical Life Systems, Inc.)
Intervention Description
TENS pads will be applied in a frame pattern around the area of maximal pain, as pointed out by the patient. The pads will be no more than 6 cm and no less than 3 cm away from the subjective area of maximal pain. The frequency of the TENS machine will be set to 100 Hz and the patient will be instructed on how to increase and decrease the amplitude based on their comfort. The patient will also be instructed on how to turn off the machine if they wish for any reason. Research assistants will be standing by during the intervention period to intervene if the patient requires assistance with the device.
Primary Outcome Measure Information:
Title
Pain Score Difference
Description
Pain score as a primary outcome will be assessed by determining the difference in VAS between T0 and T60. VAS is a validated tool for measuring subject reports of pain in a variety of patient care settings. T60 was chosen as the primary endpoint as this was thought to allow sufficient time for standard care (ie. pharmacotherapy) to take effect. A clinically significant reduction of pain was defined as 30% on VAS, based on prior literature.
Time Frame
Change from baseline score at 60 minutes of study participation.
Secondary Outcome Measure Information:
Title
Pain score at T30
Description
As a secondary outcome, pain score reduction at T30 will be assessed. This is to determine how effective TENS is at reduction pain immediately when finishing treatment. Similarly, a 30% reduction of pain score is considered clinically significant. No further assessment points will be used due to the variability of wait-times and high likelihood of loss to follow-up with later assessment points. We currently do not have capacity for telephone follow-up the next day.
Time Frame
After 30 minutes of study participation.
Title
Opioid requirements
Description
A further secondary outcome is opioid requirements while in the ED, calculated by Oral Morphine Equivalents (OMEs). The duration of 8 hours or at time of discharge was determined to be an adequate length of time to allow for appropriate up-titration of opioids to achieve adequate pain treatment. Other forms of analgesia (ie. NSAIDs and acetaminophen) will not be tallied, due to the challenge of reliably interpreting the data - most patients have taken some form of over-the-counter analgesia prior to their ED encounter and different NSAIDs are often used without a reliable way of determining comparable such as OMEs for opioids.
Time Frame
After 60 minutes of study participation.
Title
ED Return Visits
Description
Return visits to the ED within 2 weeks will also be compared between groups, specifically analyzing the proportion of repeat presentations with a triage complaint of "back pain." This will be done by accessing the EMR of each patient in the trial through by the PI or CIs. Presentations to all EDs in the Island Health region are available upon accessing our local EMR (PowerChart). No further details other than initial triage complaint will be collected on these repeat visits.
Time Frame
Within 2 weeks of study participation.
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Adverse effects will also be gathered, including skin irritation and pad removal due to discomfort. Any other suspected adverse events will be recorded and reported in a narrative format.
Time Frame
Immediately after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older.
Acute or acute-on-chronic back pain, defined as less than 3 weeks of increased symptoms.
Canadian Triage and Acuity Scale (CTAS) level 3-5 in ambulatory section of emergency department8.
Projected wait-time of at least 30 minutes.
Comfortable with communication in English. Unfortunately, currently, we do not have the capacity or funding to hire a translator to translate our study documents or communicate with potential study participants.
Exclusion Criteria:
Back pain "red flags" on initial history. These include:
Patient reported fever.
Recent direct blunt or penetrating trauma to the back, perceived by the patient to be the cause of acute pain or exacerbation of chronic pain.
Bilateral radicular symptoms.
Changes in ability to empty bladder or urinary incontinence since onset of back pain.
Incontinence of stool.
Saddle anesthesia.
Intravenous drug use within the last 30 days.
History of spinal cord injury.
Epilepsy.
Abnormal triage vital signs:
Temperature greater than 38 C
Abnormal blood pressure (BP) defined as systolic BP less than 90 or over 180.
Tachypnea with respiratory rate (RR) greater than 22.
Active pregnancy (patient warning on product label)
Canadian Triage and Acuity Scale (CTAS) level 1-2.
Implanted pacemaker or neurostimulation device.
TENS unit in use by another patient at time of screening
Wound, abrasion, rash over where TENS pads will be placed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Brophy
Organizational Affiliation
Island Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED)
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