Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS) unit

Device

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.

Primary outcomes

Self Report on Visual Analog Scale for Pain (VAS Pain)

Time frame: completion of study, one day

Determining the change in discomfort associated with medication before and after the administration of the TENS therapy. The Visual Analogue Scale consists of a straight line with the endpoints defining extreme limits such as "0" 'no pain at all' and "8" 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints "0" - "8". The distance between "0" 'no pain at all' and the mark then defines the subject's pain.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2026
First posted: Aug 15, 2019
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting