← Back to Search

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.

Must not have

Subject under 18 years of age.

Subject not receiving biologic medication injection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of study, one day

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 18 years old.

Select...

I am not currently taking any injected biologic medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of study, one day

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met