Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

Renal Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237208
• Other study ID #: 08.06.2017/02
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: September 8, 2017
• Start date: June 12, 2017
• Est. completion date: August 20, 2017

Study information

• Verified date: September 2017
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 20, 2017
• Est. primary completion date: August 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Device:
• TENS
Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.
• placebo group
Transcutaneous electrical nerve stimulation treatment will not be activated.

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman	Central

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Simpson PM, Fouche PF, Thomas RE, Bendall JC. Transcutaneous electrical nerve stimulation for relieving acute pain in the prehospital setting: a systematic review and meta-analysis of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):10-7. doi: 10.1097/MEJ.0b013e328363c9c1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	30 minutes after taking Transcutaneous Electrical Nerve Stimulation application	30 minutes after