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TENS for Psoriasis Injection Pain

N/A
Waitlist Available
Led By Steven R Feldman, M.D., Ph.D
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study, one day
Awards & highlights

Study Summary

This trial is testing whether TENS therapy can reduce pain during and after the injection of biological medications. 10-20 subjects will be recruited and will receive the injection in one thigh with and one without the use of TENS therapy.

Who is the study for?
This trial is for adults over 18 with psoriasis who are currently receiving biologic medication injections at two sites during their clinic visits. Participants must understand English and be able to provide feedback on pain levels.Check my eligibility
What is being tested?
The study tests if TENS, a method using electrical nerve stimulation, can reduce the pain of biologic injection in patients with psoriasis. It involves comparing pain levels during one regular injection and another with TENS applied near the injection site.See study design
What are the potential side effects?
TENS therapy may cause skin irritation where pads are placed, muscle twitching, or discomfort from the electrical current. However, it's generally considered safe and side effects are typically mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have psoriasis and get biologic injections at two sites during my clinic visits.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of study, one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of study, one day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self Report on Visual Analog Scale for Pain (VAS Pain)

Trial Design

1Treatment groups
Experimental Treatment
Group I: TENS therapyExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,187 Total Patients Enrolled
12 Trials studying Psoriasis
983 Patients Enrolled for Psoriasis
Steven R Feldman, M.D., Ph.DPrincipal InvestigatorWake Forest University Health Sciences

Media Library

transcutaneous electrical nerve stimulation (TENS) unit Clinical Trial Eligibility Overview. Trial Name: NCT04058652 — N/A
Psoriasis Research Study Groups: TENS therapy
Psoriasis Clinical Trial 2023: transcutaneous electrical nerve stimulation (TENS) unit Highlights & Side Effects. Trial Name: NCT04058652 — N/A
transcutaneous electrical nerve stimulation (TENS) unit 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must an individual meet in order to qualify for participation in this experimental program?

"This clinical trial is seeking 20 psoriasis patients between 18 and 64 years old that meet certain criteria. Specifically, participants must be receiving a biologic injection at two sites during their clinic visit as part of their management, have some level of knowledge in English, and are 18 or older."

Answered by AI

Are participants still being enrolled for this research endeavor?

"The details available on clinicaltrials.gov demonstrate that this study, which was first posted in August of 2019, is no longer seeking participants. Nevertheless, there are 167 other medical trials actively recruiting patients at the present moment."

Answered by AI

Are adolescents or young adults able to partake in this experiment?

"This medical trial is enrolling individuals between 18 and 64 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)
2019. "Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04058652.
All > Psoriasis > Plaque Psoriasis
~2 spots leftby Nov 2024
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