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NCT04058652 · ClinicalTrials.gov registry record · NA
Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)
A NA study of Psoriasis, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04058652: Active NA study of Psoriasis, sponsored by Wake Forest University Health Sciences.
NCT04058652 is a NA study of Psoriasis that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 20 participants, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04058652, a NA study of Psoriasis, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE transcutaneous electrical nerve stimulation (TENS) unit
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT04058652 still lists
NCT04058652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 1 intervention - of which transcutaneous electrical nerve stimulation (TENS) unit is the first listed.
NCT04058652 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04058652 about?
NCT04058652 is a clinical study titled "Use of Transcutaneous Electrical Nerve Stimulation for Reducing Biologic Injection Site Pain(TENS Study)". 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 interven...
What is the current status of trial NCT04058652?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2019-08-07. Estimated completion is 2026-12.
What conditions does trial NCT04058652 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT04058652?
The interventions under investigation include: transcutaneous electrical nerve stimulation (TENS) unit (DEVICE).
Who is sponsoring clinical trial NCT04058652?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04058652 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04058652's enrollment target sits among peer trials
20 107th of 125 higher than 16 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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