Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)
Public ClinicalTrials.gov record NCT04058652. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study is to determine the efficacy of TENS therapy in reducing the pain experienced by patients during and after the injection of biological medications. The study team is interested in recording the level of pain reduction from TENS therapy to determine if this intervention is effective at reducing discomfort associated with medication administration so that it may possibly be applied to other patients in an effort to reduce treatment-related discomfort, anxiety, and possibly increase adherence. 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.
Study identification
- NCT ID
- NCT04058652
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2019
- Primary completion
- Dec 31, 2026
- Completion
- Jun 30, 2027
- Last update posted
- Aug 3, 2026
2019 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04058652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04058652 live on ClinicalTrials.gov.