Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)
NCT ID: NCT04058652
Last Updated: 2025-12-17
Study Results
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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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2019-08-07
2026-12-31
Brief Summary
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A total of 10-20 subjects at one research site will be recruited to participate, specifically, individuals who receive the injection of medication in two separate sites. The inclusion criteria will be an age of \> 18 years old, a diagnosis of psoriasis, and currently receiving biologic medication injection in two sites during their dermatology clinic visit.
The first step is to administer the biologic medication in one thigh without the use of TENS therapy. This is done to establish a control, or baseline, for how painful the injection experience is. The second step involves a study team member applying two to four TENS unit pads (made of adhesive gel) to the skin of your thigh approximately two centimeters from the site where injection of the biological medication takes place. The device will be turned on during the injection of the medication. Medication injection will take place by either the patient or nursing staff as it would normally take place without involvement in this study. Immediately after both steps, subjects will be given a brief survey to determine their pain level.
Detailed Description
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The first step is to administer the biologic medication in one thigh without the use of TENS therapy. This is done to establish a control, or baseline, for how painful the injection experience is. The second step involves a study team member applying two to four TENS unit pads (made of adhesive gel) to the skin of your thigh approximately two centimeters from the site where injection of the biological medication takes place. The device will be turned on during the injection of the medication. Medication injection will take place by either the patient or nursing staff as it would normally take place without involvement in this study. Immediately after both steps, subjects will be given a brief survey to determine their pain level.
The study will be conducted at Department of Dermatology at Wake Forest School of Medicine. Data will also be analyzed at Department of Dermatology at Wake Forest School of Medicine.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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TENS therapy
the first step would be to administer the biologic medication in one thigh without the use of TENS therapy. Biologic medications are administered in two doses, with one in each thigh. Administering the first biologic medication injection is done to establish a control, or baseline, for how painful the injection experience is. The second step would be a study team member applying two to four TENS unit pads (made of adhesive gel) to the skin of subject's other thigh approximately two centimeters from the site where injection of the biological medication takes place. There will be no extra injection of biologic medication during this procedure. The prescribed dose will be used one time, split into two legs (which is the standard protocol for administration). The device will be turned on during the injection of the medication. Immediately after both steps, the subject will be given a brief survey to determine your pain level. The subject's involvement would last roughly 10-15 minutes.
transcutaneous electrical nerve stimulation (TENS) unit
The transcutaneous electrical nerve stimulation (TENS) unit is a noninvasive, inexpensive, battery-operated device that was originally designed to provide modulation of the afferent nervous system to relieve pain. By providing alternating current through cutaneous electrodes, TENS activates large-diameter afferent fibers of the nervous system (A-delta, A-beta, C fibers), whose ascending signals are subsequently relayed to the central nervous system.
Interventions
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transcutaneous electrical nerve stimulation (TENS) unit
The transcutaneous electrical nerve stimulation (TENS) unit is a noninvasive, inexpensive, battery-operated device that was originally designed to provide modulation of the afferent nervous system to relieve pain. By providing alternating current through cutaneous electrodes, TENS activates large-diameter afferent fibers of the nervous system (A-delta, A-beta, C fibers), whose ascending signals are subsequently relayed to the central nervous system.
Eligibility Criteria
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Inclusion Criteria
* Subject is 18 years of age or older.
* Subject has a working knowledge of English.
Exclusion Criteria
* Subject under 18 years of age.
* Subject does not have a working knowledge of English.
18 Years
64 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Steven R Feldman, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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IRB00059331
Identifier Type: -
Identifier Source: org_study_id