Back PainTENS-EDNCT05601843
Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED)
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Back Pain and Muscle Pain, run by Sam Brophy at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Muscle Pain, Acute Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 8 May 2023to 19 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Low Back Pain in the Emergency Department
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.
Read the 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?"
- Conditions
- Back Pain, Muscle Pain, Acute Pain, Lower Back Pain, Lower Back Pain Mechanical
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Back pain, Mechanical back pain, Lower back pain, TENS, Transcutaneous Electrical Nerve Stimulation, Emergency, Emergency Department, Acute pain
- Medical subject headings
- Back Pain, Myalgia, Acute Pain, Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called Impulse® 3000 T (© 2014 BioMedical Life Systems, Inc.)
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.
| Study group | Role | What they receive |
|---|---|---|
| TENS Arm | Experimental | Participants randomized to receive treatment with TENS in addition to standard care. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Control Arm | No intervention | Participants randomized to not receive treatment with TENS. These participants receive standard care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline score at 60 minutes of study participation.
Secondary outcomes (3)
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.
Measured: After 30 minutes of study participation.
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.
Measured: After 60 minutes of study participation.
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.
Measured: Within 2 weeks of study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start8 May 2023
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sam Brophy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sam Brophy, Vancouver Island Health Authority
- Investigators
- Samuel Brophy, Principal investigator, Island Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601843
- Sponsor's protocol ID
- H21-02812
- Acronym
- TENS-ED
- Status last verified
- Jun 2023
- First submitted
- 17 Oct 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Low Back Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT05601843
- Acronym / sponsor ID
- TENS-ED / H21-02812
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sam BrophyUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 1 Nov 2022 (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.
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?"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Arm | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants randomized to receive treatment with TENS in addition to standard care. |
| Control Arm | No intervention | –Participants randomized to not receive treatment with TENS. These participants receive standard care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- Back pain "red flags" on initial history. These include:
- History of spinal cord injury.
- Epilepsy.
- Abnormal triage vital signs:
- Active pregnancy (patient warning on product label)
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 Stimulation (TENS)Also: Impulse® 3000 T (© 2014 BioMedical Life Systems, Inc.)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. | Device | TENS Arm |
Primary outcome
Pain Score Difference
Time frame: Change from baseline score at 60 minutes of study participation.
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.
3 secondary outcomes
Pain score at T30
Time frame: After 30 minutes of study participation.
Opioid requirements
Time frame: After 60 minutes of study participation.
ED Return Visits
Time frame: Within 2 weeks of study participation.
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 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Samuel Brophy principal investigator
Island Health
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 (TENS) in people with Back Pain and Muscle Pain, run by Sam Brophy at 1 site in Canada.
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 5 inclusion and 19 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 18 Jun 2023. 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 Canada. 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. 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?
Pain Score Difference (time frame: Change from baseline score at 60 minutes of study participation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.