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

NCT05601843 | Completed

• 1 other identifier: H21-02812
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline score at 60 minutes of study participation.

Secondary Outcomes (3)

• Pain score at T30

  After 30 minutes of study participation.

• Opioid requirements

  After 60 minutes of study participation.

• ED Return Visits

  Within 2 weeks of study participation.

Other Outcomes (1)

• Adverse effects

  Immediately after intervention.

Study Arms (2)

TENS Arm

EXPERIMENTAL

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

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Control Arm

NO INTERVENTION

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

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) 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.

Also known as: Impulse® 3000 T (© 2014 BioMedical Life Systems, Inc.)

TENS Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sam Brophy: lead

Study Sites (1)

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

MeSH Terms

Conditions

Back Pain; Myalgia; Acute Pain; Low Back Pain; Emergencies

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Samuel Brophy

  Island Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 1, 2022
• Study Start: May 8, 2023
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)