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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03790514
Other study ID # AksarayUTRH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2018
Est. completion date March 20, 2019

Study information

Verified date December 2018
Source Aksaray University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date March 20, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with renal colic

Exclusion Criteria:

- Pregnants

- Known allergies to heat tapes

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Murat Gül Aksaray

Sponsors (1)

Lead Sponsor Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Scale 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
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