Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

Study Overview
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Brief Summary
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The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.

Detailed Description
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Renal colic, an intensely painful condition, is a common presenting complaint to the emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and acetaminophen are commonly used to provide relief from renal colic. The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department. Study Design and Setting: A prospective, randomized, double-blind, placebo controlled, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.

Official Title
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Patients Undergoing Routine Transcutaneous Electrical Nerve Stimulation Treatment in Patients With Renal Colic Who Admitted to the Emergency Department: A Randomized Double Blind Placebo-controlled Trial

Conditions
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Renal Colic

Intervention / Treatment
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* Device: TENS
* Device: placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with renal colic admitted to emergency department. Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography Exclusion Criteria: Patients below 18 years of age Patients with haemodynamic instability, with fever (temperature=38°C [100.4°F]), with evidence of peritoneal inflammation, Patients using any analgesic within the previous 48 hours of emergency department presentation Patients who declined to participate

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>Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere | Device: TENS<br>* Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.<br>|
| Sham Comparator: placebo group<br>Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated. | Device: placebo group<br>* Transcutaneous electrical nerve stimulation treatment will not be activated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the intensity of pain | Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application | 0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application | 30 minutes after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous electrical nerve stimulation, emergency medicine