Skip to content

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

Effect of Local Cooling of Testis in Patient With Epididymitis on Analgetics Consumption and Pain Level

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943772
Enrollment
60
Registered
2016-10-25
Start date
2016-09-30
Completion date
2020-11-30
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief 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.

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.

Interventions

OTHERLocal hypothermia

Cooled brick

OTHERControl

Control brick

Sponsors

Kaplan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patient unable to informed consent * Suspicion of testicular malignancy

Design outcomes

Primary

MeasureTime frameDescription
change in pain levelpain 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 50weeksintervention and measurement will be examined three times a day following brick/cooled brick

Secondary

MeasureTime frameDescription
Total consumption in grams of protocol analgeticsanalgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weekseach protocol Analgetic will be summarized individually in grams

Countries

Israel

Contacts

Primary ContactIgal Shpunt, MD
igal2k@gmail.com+972-8-944-1642
Backup ContactYuval Avda, MD
yuvalab@clalit.org.il+972-8-944-1516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026