Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake?

NCT ID: NCT02943772

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-11-30

Brief Summary

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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

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Local hypothermia

Local application of a brick cooled to -20(celsius)

Group Type EXPERIMENTAL

Local hypothermia

Intervention Type OTHER

Cooled brick

Control

Local application of a brick in room temperature

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

Control brick

Interventions

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Local hypothermia

Cooled brick

Intervention Type OTHER

Control

Control brick

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male patients 18-99 years
* Acute epididymitis or acute orchiepididymitis

Exclusion Criteria

* Patient unable to informed consent
* Suspicion of testicular malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kaplan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dan Leibovici

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Leibovici, MD

Role: PRINCIPAL_INVESTIGATOR

Kapaln medical center

Locations

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Kaplan Medical Center

Rehovot, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Igal Shpunt, MD

Role: CONTACT

+972-8-944-1642

Yuval Avda, MD

Role: CONTACT

+972-8-944-1516

Facility Contacts

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igal shpunt, MD

Role: primary

972545857588

Other Identifiers

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0092-16-KMC

Identifier Type: -

Identifier Source: org_study_id

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