TENS for Back Pain Emergency Department
The Use of TENS for the Treatment of Back Pain in the Emergency Department
1 other identifier
interventional
80
1 country
1
Brief Summary
In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2024
CompletedFebruary 13, 2024
February 1, 2024
4.1 years
January 10, 2020
February 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain severity
Pain severity graded on a verbal numeric pain scales from none (0) to most (10)
30 minutes after application of TENS unit
Secondary Outcomes (1)
Use of rescue medications
30 minutes after application of the TENS unit
Study Arms (2)
TENS
ACTIVE COMPARATORA TENS device consists of an electric pulse generator and pads that are attached to the skin on around the area of maximal pain. We will use the conventional mode, which provides nerve stimulation with a pulse width of 60 microseconds and a pulse rate of 60 pulses per second. The channel intensity will be gradually increased until the intensity is noticeable but not painful.
SHAM TENS
SHAM COMPARATORIn the SHAM TENS group the TENS pads will be attached to the pulse generator and the patients skin around the painful area. The investigator will turn the knobs on but the batteries will be removed from the device.
Interventions
Eligibility Criteria
You may qualify if:
- Adults age 18 years or greater
- Able to consent
- Back pain of less than 2 weeks duration
- Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)
You may not qualify if:
- Pregnant patients
- Minors
- Prisoners
- Neurological deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Related Publications (1)
Otterness K, McMahon B, Ma M, Thode HC Jr, Singer AJ. The use of TENS for the treatment of back pain in the emergency department: A randomized controlled trial. Acad Emerg Med. 2025 Aug;32(8):828-835. doi: 10.1111/acem.70013. Epub 2025 Apr 9.
PMID: 40202296DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Singer, MD
Stony Brook University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Vice Chairman for Research
Study Record Dates
First Submitted
January 10, 2020
First Posted
January 13, 2020
Study Start
January 20, 2020
Primary Completion
February 12, 2024
Study Completion
February 12, 2024
Last Updated
February 13, 2024
Record last verified: 2024-02