PainNCT02943772
Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake?
A study testing Local hypothermia in people with Pain, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Pain
- What is being tested?
- Local hypothermia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Nov 2020
- 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients 18-99 years
- Acute epididymitis or acute orchiepididymitis
Who cannot join
- Patient unable to informed consent
- Suspicion of testicular malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot
igal shpunt, MD, 972545857588, igal2k@gmail.com
Uri lindner, MD
About this study
Official title: Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level
The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.
Read the detailed description
Epididymitis or orchiepididymitis is an acute disease causing pain and discomfort.
our hypothesis is that local cooling of the affected testis or epididymis may relieve the pain and reduce the analgetics consumption In order to examine this hypothesis we will recruit adult patients with epididymitis or orchiepididymitis and will randomize these patients to two arms.
One arm will receive every 8 hours a brick cooled for at least 2 hours in -20(celsius) for local use on the affected hemiscrotum, while the second arm will receive a brick in room temperature.
Pain level will be estimated one hour following the application of the brick using visual analogue pain score. Patient will receive analgetics according to a predefined escalating protocol.
Pain level and analgetics consumption will be compared between the two arms.
- Conditions
- Pain
- Being tested
- Local hypothermia, Control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local hypothermiaOther
Cooled brick
ControlOther
Control brick
| Study group | Role | What they receive |
|---|---|---|
| Local hypothermia | Experimental | Local application of a brick cooled to -20(celsius) Receives: Other: Local hypothermia |
| Control | Sham comparator | Local application of a brick in room temperature Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain level
intervention and measurement will be examined three times a day following brick/cooled brick
Measured: pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
Secondary outcomes (1)
Total consumption in grams of protocol analgetics
each protocol Analgetic will be summarized individually in grams
Measured: analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion7 Nov 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Leibovici, Kaplan Medical Center
- Investigators
- Dan Leibovici, MD, Principal investigator, Kapaln medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943772
- Sponsor's protocol ID
- 0092-16-KMC
- Status last verified
- Aug 2019
- First submitted
- 26 Sep 2016
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level
- ClinicalTrials.gov ID
- NCT02943772
- Acronym / sponsor ID
- 0092-16-KMC
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 7 Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 25 Oct 2016 (estimated)
- 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.
The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.
Detailed description
Epididymitis or orchiepididymitis is an acute disease causing pain and discomfort.
our hypothesis is that local cooling of the affected testis or epididymis may relieve the pain and reduce the analgetics consumption In order to examine this hypothesis we will recruit adult patients with epididymitis or orchiepididymitis and will randomize these patients to two arms.
One arm will receive every 8 hours a brick cooled for at least 2 hours in -20(celsius) for local use on the affected hemiscrotum, while the second arm will receive a brick in room temperature.
Pain level will be estimated one hour following the application of the brick using visual analogue pain score. Patient will receive analgetics according to a predefined escalating protocol.
Pain level and analgetics consumption will be compared between the two arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local hypothermia | Experimental | Other: Local hypothermiaLocal application of a brick cooled to -20(celsius) |
| Control | Sham comparator | Other: ControlLocal application of a brick in room temperature |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients 18-99 years
- Acute epididymitis or acute orchiepididymitis
Key exclusion criteria (2 listed)
- Patient unable to informed consent
- Suspicion of testicular malignancy
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 |
|---|---|---|
| Local hypothermiaCooled brick | Other | Local hypothermia |
| ControlControl brick | Other | Control |
Primary outcome
change in pain level
Time frame: pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
intervention and measurement will be examined three times a day following brick/cooled brick
1 secondary outcome
Total consumption in grams of protocol analgetics
Time frame: analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- 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.
Dan Leibovici, MD principal investigator
Kapaln medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local hypothermia in people with Pain, run by Kaplan Medical Center at 1 site in Israel.
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 2 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 16 Aug 2019. 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 Israel. 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?
Contact Igal Shpunt, MD (+972-8-944-1642, igal2k@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain level (time frame: pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks). 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 16 Aug 2019.