TENS for Psoriasis Injection Pain

Recruiting in Palo Alto (17 mi)

Overseen bySteven Feldman, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

I have psoriasis and get biologic injections at two sites during my clinic visits.

I am 18 years old or older.

Subject has a working knowledge of English.

Exclusion Criteria

I am younger than 18 years old.

Subject does not have a working knowledge of English.

I am not currently taking any injected biologic medications.

Treatment Details

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) Therapy (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.