NCT04058652Active, not recruiting
Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)
Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 Aug 2019
- Start date
- 7 Aug 2019
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Psoriasis
- NCT number
- NCT04058652
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 7 Aug 2019 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject not receiving biologic medication injection.
Age
- Subject under 18 years of age.
Other
- Subject does not have a working knowledge of English.
Who the study is looking for
- Subject has a diagnosis of psoriasis and receiving biologic medication injection in two sites during their clinic visit as part of their management.
- Subject is 18 years of age or older.
- Subject has a working knowledge of English.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.