- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790514
Heat Wrap for Renal Colic
Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aksaray, Turkey, 68000
- Recruiting
- Murat Gül
-
Contact:
- Murat Gül
- Phone Number: 905056316913
- Email: drgulacademics@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with renal colic
Exclusion Criteria:
- Pregnants
- Known allergies to heat tapes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Group
|
Commercially heat tapes ( without drugs) will be applied to patients.
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Experimental: Heat Wrap Group
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Commercially heat tapes ( without drugs) will be applied to patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AksarayUTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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