Renal ColicNCT03790514
Heat Wrap for Renal Colic
A study testing Heat Wrap in people with Renal Colic, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Colic
- What is being tested?
- Heat Wrap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with renal colic
Who cannot join
- Pregnants
- Known allergies to heat tapes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Murat Gül
Aksaray, 68000
Murat Gül, 905056316913, drgulacademics@gmail.com
About this study
Official title: 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.
- Conditions
- Renal Colic
- Being tested
- Heat Wrap
- Keywords
- Heat wrap
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat WrapOther
Commercially heat tapes ( without drugs) will be applied to patients.
| Study group | Role | What they receive |
|---|---|---|
| Heat Wrap Group | Experimental | Not described Receives: Other: Heat Wrap |
| Control Group | Placebo comparator | Not described Receives: Other: Heat Wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start30 Nov 2018
- Primary completion28 Feb 2019 (estimated)
- Study completion20 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Gül, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790514
- Sponsor's protocol ID
- AksarayUTRH
- Status last verified
- Dec 2018
- First submitted
- 28 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Therapy for Pain Management in Patients With Renal Colic: Heat Wrap
- ClinicalTrials.gov ID
- NCT03790514
- Acronym / sponsor ID
- AksarayUTRH
- Conditions
- Renal Colic
- Keywords
- Heat wrap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 20 Mar 2019 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat Wrap Group | Experimental | Other: Heat Wrap |
| Control Group | Placebo comparator | Other: Heat Wrap |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with renal colic
Key exclusion criteria (2 listed)
- Pregnants
- Known allergies to heat tapes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat WrapCommercially heat tapes ( without drugs) will be applied to patients. | Other | Control Group, Heat Wrap Group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat Wrap in people with Renal Colic, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Scale (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.