Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

Not Applicable

Completed

• Conditions: Renal Colic
• Interventions: Device: TENS; Device: placebo group

• Registration Number: NCT03237208
• Lead Sponsor: Adiyaman University Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-06-12
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-02
• Primary Completion: 2017-08-12
• Study Completion: 2017-08-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Adult patients with renal colic admitted to emergency department.
2. Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography

Exclusion Criteria

1. Patients below 18 years of age
2. Patients with haemodynamic instability, with fever (temperature=38°C [100.4°F]), with evidence of peritoneal inflammation,
3. Patients using any analgesic within the previous 48 hours of emergency department presentation
4. Patients who declined to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS	TENS	Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
placebo group	placebo group	Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.

Primary Outcome Measures

Name	Time	Method
Reduction of the intensity of pain	0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application	Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application

Secondary Outcome Measures

Name	Time	Method
Adverse events	30 minutes after	30 minutes after taking Transcutaneous Electrical Nerve Stimulation application

Trial Locations

Locations (1)

Adiyaman University Research Hospital; 🇹🇷 Adıyaman, Central, Turkey