Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED)

NCT ID: NCT05601843

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2023-05-19

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?"

Conditions

Back Pain; Muscle Pain; Acute Pain; Lower Back Pain; Lower Back Pain Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TENS Arm

Participants randomized to receive treatment with TENS in addition to standard care.

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: DEVICE

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.

Control Arm

Participants randomized to not receive treatment with TENS. These participants receive standard care only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Intervention Type: DEVICE

Other Intervention Names

Impulse® 3000 T (© 2014 BioMedical Life Systems, Inc.)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sam Brophy

OTHER

Sponsor Role: lead

Responsible Party

Sam Brophy

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samuel Brophy

Role: PRINCIPAL_INVESTIGATOR

Island Health

Locations

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Countries

Canada

Other Identifiers

H21-02812

Identifier Type: -

Identifier Source: org_study_id