Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

NCT03237208 | Completed DMC

• 1 other identifier: 08.06.2017/02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Colic

Keywords

Transcutaneous electrical nerve stimulation; emergency medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  30 minutes after

Study Arms (2)

TENS

ACTIVE COMPARATOR

Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere

Device: TENS

placebo group

SHAM COMPARATOR

Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.

Device: placebo group

Interventions

TENS DEVICE

Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.

TENS

placebo group DEVICE

Transcutaneous electrical nerve stimulation treatment will not be activated.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, Central, 02000, Turkey (Türkiye)

Location

Related 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.

  PMID: 23839103 BACKGROUND

MeSH Terms

Conditions

Renal Colic

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Umut Gulacti, M.D.

  Adiyaman University of Medical Faculty

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 2, 2017
• Study Start: June 12, 2017
• Primary Completion: August 12, 2017
• Study Completion: August 20, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

TU (1)