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Clinical Trial

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

NCT: NCT04058652 · ACTIVE_NOT_RECRUITING

NCT IDNCT04058652
StatusACTIVE_NOT_RECRUITING
Start Date2019-08-07
Completion2027-07
SponsorWake Forest University Health Sciences (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is 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(TENS Study) is a clinical trial registered under NCT04058652. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT04058652?

The current status of NCT04058652 (Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)) is: ACTIVE_NOT_RECRUITING.

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

Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study) started on 2019-08-07.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.