- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058652
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TENS therapy
the first step would be to administer the biologic medication in one thigh without the use of TENS therapy.
Biologic medications are administered in two doses, with one in each thigh.
Administering the first biologic medication injection is done to establish a control, or baseline, for how painful the injection experience is.
The second step would be a study team member applying two to four TENS unit pads (made of adhesive gel) to the skin of subject's other thigh approximately two centimeters from the site where injection of the biological medication takes place.
There will be no extra injection of biologic medication during this procedure.
The prescribed dose will be used one time, split into two legs (which is the standard protocol for administration).
The device will be turned on during the injection of the medication.
Immediately after both steps, the subject will be given a brief survey to determine your pain level.
The subject's involvement would last roughly 10-15 minutes.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self Report on Visual Analog Scale for Pain (VAS Pain)
Time Frame: completion of study, one day
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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.
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completion of study, one day
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Collaborators and Investigators
Investigators
- Principal Investigator: Steven R Feldman, M.D., Ph.D, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00059331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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