TENS for Back Pain Emergency Department

Study Overview
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Brief Summary
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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.

Detailed Description
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Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their pain.

Official Title
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The Use of TENS for the Treatment of Back Pain in the Emergency Department

Conditions
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Back Pain

Intervention / Treatment
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* Device: TENS
* Device: SHAM TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Pregnant patients Minors Prisoners Neurological deficits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS<br>A 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. | Device: TENS<br>* An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.<br>|
| Sham Comparator: SHAM TENS<br>In 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. | Device: SHAM TENS<br>* A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue medications | The percentage of patients that were administered an additional analgesic medication after the application of TENS | 30 minutes after application of the TENS unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, back pain, ibuprofen