Clinical trial NCT04058652: Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)
Official title: Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psoriasis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subject not receiving biologic medication injection.
* Subject under 18 years of age.
* Subject does not have a working knowledge of English.

Primary outcomes:
measure: Self Report on Visual Analog Scale for Pain (VAS Pain)
timeFrame: completion of study, one day
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: