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Heat Wrap for Renal Colic

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ClinicalTrials.gov Identifier: NCT03790514
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Murat Gül, Aksaray University Training and Research Hospital

Brief Summary:

Non-steroidal anti-inflammatory drugs (NSAIDs) (diclofenac, kotorolac, piroxicam) opioids (petidine, tramadol, fentanyl), paracetamol and topical agents (EMLA, diclofenal gel), have been shown to be effective in the treatment of renal colic . NSAIDs are commonly used to treat renal colic, but they can reduce renal blood flow and cause kidney damage. In addition, there are limitations in use in cases such as gastrointerstinal ulcers, hepatic insufficiency and chronic obstructive pulmonary disease. Gastrointestinal complications (ulcers, reflux, etc.) may cause hypersensitivity reactions (allergy) and coagulation disorders. On the other hand, opioids may cause nausea, vomiting, hypotension, sedation, dizziness and even respiratory depression. In addition to these pharmacological agents, stair-stroke, Turkish bath, blanket or hot water bag and local warming are now used in the treatment of renal colic in traditional methods.

Heat Wrap is an effective, natural solution designed to remove muscle pain with the help of heat and used regularly by physical therapists. The heat wrap is activated by air contact within a few minutes after its removal from its sheet and does not contain any drugs. It contains heat from the active iron particles in contact with air. After a few minutes of application, it begins to spread the natural, long-term (8 hours) heat by targeting the source of the pain. The patient satisfaction is high because it is odorless and thin.

In the literature, considering the success of heat therapy in patients with renal colic (bath entrance, electric blanket heating) in this study we have aimed to evaluate the efficacy of alternative treatment with pain-relieving alternative treatments with little potential for side effects and to see its applicability in daily treatment plans.


Condition or disease Intervention/treatment Phase
Renal Colic Other: Heat Wrap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 20, 2019

Arm Intervention/treatment
Experimental: Heat Wrap Group Other: Heat Wrap
Commercially heat tapes ( without drugs) will be applied to patients.

Placebo Comparator: Control Group Other: Heat Wrap
Commercially heat tapes ( without drugs) will be applied to patients.




Primary Outcome Measures :
  1. Pain Intensity Scale [ Time Frame: 1 hour ]
    Self reported pain intensity (VAS 0-10) after applying heat wrap. Each item is scored between 0-10. While 0 shos no pain, 10 is the greatest pain the patient has experienced



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Patients with renal colic

Exclusion Criteria:

  • Pregnants
  • Known allergies to heat tapes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790514


Locations
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Turkey
Murat Gül Recruiting
Aksaray, Turkey, 68000
Contact: Murat Gül    905056316913    drgulacademics@gmail.com   
Sponsors and Collaborators
Aksaray University Training and Research Hospital

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Responsible Party: Murat Gül, Assistant Professor, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03790514     History of Changes
Other Study ID Numbers: AksarayUTRH
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murat Gül, Aksaray University Training and Research Hospital:
Heat wrap
Additional relevant MeSH terms:
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Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Signs and Symptoms