Heat Wrap for Renal Colic
Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2018
CompletedFirst Submitted
Initial submission to the registry
December 28, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedDecember 31, 2018
December 1, 2018
3 months
December 28, 2018
December 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Heat Wrap Group
EXPERIMENTALControl Group
PLACEBO COMPARATORInterventions
Commercially heat tapes ( without drugs) will be applied to patients.
Eligibility Criteria
You may qualify if:
- \- Patients with renal colic
You may not qualify if:
- Pregnants
- Known allergies to heat tapes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Murat Gül
Aksaray, 68000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 28, 2018
First Posted
December 31, 2018
Study Start
November 30, 2018
Primary Completion
February 28, 2019
Study Completion
March 20, 2019
Last Updated
December 31, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share