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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04058652
• Other study ID #: IRB00059331
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Report on Visual Analog Scale for Pain (VAS Pain)	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.	completion of study, one day