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Behavioural Intervention
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management
N/A
Waitlist Available
Led By Amy M Pearlman, MD
Research Sponsored by Jennifer E. Lee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years to 99;
Diagnosis of Idiopathic Chronic Orchialgia (ICO)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this outcome measure will be used at the start of the study (after they consent; baseline). pcs scores range from 0-52 and higher scores mean worse catastrophizing. a decrease in pcs scores is a good outcome.
Awards & highlights
Study Summary
TENS for Testicular Pain (ICO): A Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this outcome measure will be used at the start of the study (after they consent; baseline). pcs scores range from 0-52 and higher scores mean worse catastrophizing. a decrease in pcs scores is a good outcome.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome measure will be used at the start of the study (after they consent; baseline). pcs scores range from 0-52 and higher scores mean worse catastrophizing. a decrease in pcs scores is a good outcome.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 10-point Numeric Pain Intensity Rating Scale (NRS) pain scores
Change in Short-Form McGill Pain Questionnaire (MPQ) Pain Scores
Secondary outcome measures
Pain Catastrophizing Scale (PCS)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: High Sensation TENSExperimental Treatment1 Intervention
Active TENS is delivered for 30mins at a frequency of 100 Hz and pulse duration of 100μsec using the EMPI Select TENS unit (calibrated using an oscilloscope prior to study). The intensity will be increased until patients feel a "maximally strong but comfortable sensation" to ensure an analgesic effect.
Group II: No Treatment ControlActive Control1 Intervention
The No Treatment Control includes application of TENS electrodes identical to the other 2 conditions, but the unit remains off. This condition will control for potential effects of repeat testing and any placebo effect.
Group III: Low Sensation TENSPlacebo Group1 Intervention
Placebo TENS parameters will be identical to Active TENS (100 Hz and 100 μsec), but a novel placebo TENS unit, previously tested and validated will be used (Rakel et al., 2010). The placebo device provides a current for 30sec and ramps off over 15sec to zero output. An indicator light remains on so it appears to the subject that the unit is still producing current. This unit has demonstrated nearly 100% blinding of investigators such that the investigator applying the TENS is unable to distinguish between the active and the placebo unit; approximately ~50% of subjects are successfully blinded using this unit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Nerve Stimulation (TENS)
2023
N/A
~680
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Who is running the clinical trial?
Jennifer E. LeeLead Sponsor
1 Previous Clinical Trials
41 Total Patients Enrolled
Amy M Pearlman, MDPrincipal InvestigatorUniversity of Iowa
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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