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TENS for Testicular Pain (ICO): A Randomized Controlled Trial

NCT04866784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-06-23

No results posted yet for this study

Summary

Idiopathic Chronic Orchialgia (i.e., testicular pain) is a challenging condition to treat, with unresolved testicular pain leading to distress, diminished activities of daily living and decreased quality of life. Testicular Pain may be caused by a tumor, hernia, infection, trauma, vein compression, cysts, and/or postoperative or radiating pain, though is often times unknown. Non-pharmacologic, conservative pain reduction interventions include heat, ice, scrotal support, physical therapy, and/or counseling, and should often be used as first line of defense. More aggressive, invasive, and non-conservative medical treatment options include medications, nerve blocks, and/or surgery, each of which may be effective, but may be invasive and/or cause serious side effects. However, there is no standard of care for managing the testicular pain and many men do not respond to current biomedical or nonpharmacologic treatment options. Novel, non-invasive treatment options are needed for ICO to improve distress, daily living activities, and quality of life. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic intervention for acute and chronic pain. This treatment involves the application of electric current through the skin; it is safe, easy to use, and inexpensive. Despite the impact and distress associated with Testicular Pain, only one known study examined the efficacy of TENS for this condition. A 2018 double-blind, randomized controlled study of people with Testicular Pain reported that TENS improved pain and quality of life significantly more than the control condition (analgesia only). This 2018 study lacked a placebo control condition (i.e., unknown whether pain relief was due to the placebo effect, where knowing an intervention is happening leads to an expectation that pain will decrease, and therefore pain perception decreases independent of the intervention). Thus, the aim of this study is to examine the efficacy of TENS on Testicular Pain using a randomized, placebo-controlled design. The results of this study will be used to inform a larger, federally-funded study.

i. Primary Aim: To assess the efficacy of TENS for Testicular Pain

ii. Secondary Aim: To assess the feasibility of TENS for Testicular Pain

iii. Third Aim: To assess the tolerability of TENS for Testicular Pain

iii. To assess associations between dispositional pain catastrophizing on responsiveness to the TENS intervention.

Conditions

  • Pain Management

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic intervention for acute and chronic pain. This treatment involves the application of electric current through the skin; it is safe, easy to use, and inexpensive

Sponsors & Collaborators

  • Jennifer E. Lee

    lead OTHER

Principal Investigators

  • Amy M Pearlman, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04866784 on ClinicalTrials.gov