TENS for Psoriasis Injection Pain

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Biologics

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether TENS therapy, which uses mild electrical currents, can reduce pain from psoriasis injections. Psoriasis patients often receive biologic medications through injections, which can be uncomfortable. Participants will receive one injection without TENS and another with TENS to compare pain levels. The trial seeks individuals who have psoriasis, are 18 or older, and receive biologic injections in two sites during clinic visits. The goal is to determine if TENS can make the injection process less painful and more manageable. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance comfort during psoriasis treatments.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since the study involves patients who are already receiving biologic medication injections, it seems likely that you can continue your current treatment.

What prior data suggests that TENS therapy is safe for reducing injection pain in psoriasis patients?

Research has shown that TENS therapy, which applies gentle electrical currents to the skin, is generally safe. Studies have found that it can reduce pain during and immediately after use without causing serious side effects. However, some individuals might experience skin issues, such as irritation or allergic reactions, from the adhesive pads used with TENS. These reactions can include redness or minor burns. Despite these potential skin problems, many individuals tolerate the treatment well, and it rarely leads to severe complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Electrical Nerve Stimulation (TENS) therapy is unique because it offers a non-invasive approach to managing injection pain for psoriasis treatments. Unlike traditional pain relief methods that might rely on medications or topical creams, TENS uses electrical impulses to potentially reduce pain perception directly at the source. This method could lead to less reliance on additional painkillers and a more comfortable experience for patients receiving biologic injections. Researchers are excited about TENS because it could significantly improve patient comfort and adherence to treatment regimens without adding more pharmaceuticals into the mix.

What evidence suggests that TENS therapy is effective for reducing injection pain in psoriasis patients?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) therapy, which participants in this trial will receive, can greatly reduce pain during or immediately after treatment. Many studies have reported positive results, making TENS a promising option for pain relief. Although experts do not fully agree on how it compares to other pain treatments, TENS has been linked to good outcomes in many cases. The therapy sends gentle electrical pulses through the skin to help ease pain. These early findings suggest that TENS could lessen discomfort from injections, offering a way to make treatments less painful. ^{2 4 6 7 8}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Subject has a working knowledge of English.

Exclusion Criteria

Subject does not have a working knowledge of English.

I am not currently taking any injected biologic medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive biologic medication injections with and without TENS therapy to assess pain reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immediate pain response using a Visual Analog Scale

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Nerve Stimulation (TENS) Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: TENS therapy Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a systematic review of 381 randomized controlled trials involving over 24,500 participants.

TENS also shows lower pain intensity compared to standard pharmacological and non-pharmacological treatments, with moderate-certainty evidence indicating it is effective and generally safe, as adverse events were mild and similar to those of comparators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). Johnson, MI., Paley, CA., Jones, G., et al.[2022]

In a study of 482 patients with chronic pain, effective patient evaluation and education were crucial for successful long-term outcomes with transcutaneous electrical nerve stimulation (TENS) therapy.

A prognostic score was developed to help select patients for TENS treatment based on various factors affecting outcomes, and this score was validated in a follow-up study with 99 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of chronic pain: predictive factors and evaluation of the method. Lampl, C., Kreczi, T., Klingler, D.[2019]

A systematic review included 12 randomized controlled trials with 919 participants to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for treating acute pain, but insufficient data prevented definitive conclusions.

The review highlighted that many studies were excluded because TENS was used alongside other treatments, indicating a need for more focused research on TENS as a standalone therapy for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. Walsh, DM., Howe, TE., Johnson, MI., et al.[2022]

In a double-blind trial with 62 participants suffering from chronic low back pain, TENS significantly reduced pain intensity compared to sham-TENS, with effects lasting up to 24 hours after treatment.

Despite the pain relief observed, there were no significant changes in plasma levels of beta-endorphin or met-enkephalin, suggesting that the mechanism of action for TENS may not involve these specific pain-relief hormones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation effects on pain-intensity and endogenous opioids levels among chronic low-back pain patients: A randomised controlled trial. Ezema, CI., Onyeso, OK., Nna, EO., et al.[2022]

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

Transcutaneous electrical nerve stimulation (TENS) was effective in reducing pain for 53% of patients with peripheral nerve damage, 75% with anginal pain from ischemic heart disease, and 69% with musculoskeletal pain, indicating its efficacy varies based on the type of pain.

While TENS had side effects in 35% of patients initially, these were generally manageable with proper guidance, highlighting the importance of support during treatment for achieving long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of pain treatment with electrostimulation: a study on TENS in patients with different pain syndromes. Meyler, WJ., de Jongste, MJ., Rolf, CA.[2019]

Transcutaneous electrical nerve stimulation (TENS) was found to be similar in efficacy to control treatments for pain relief in chronic back pain, indicating it may not be a superior option for managing pain compared to sham or placebo treatments.

However, TENS showed a significant short-term improvement in functional disability for patients with follow-up of less than 6 weeks, suggesting it may be beneficial for improving daily function in the early stages of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain. Wu, LC., Weng, PW., Chen, CH., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-psoriasis-7-2019-c13aa

TENS for Psoriasis Injection Pain · Info for Participants Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a ...

2. mdpi.com mdpi.com/1422-0067/25/23/13005

Electrostimulation: A Promising New Treatment for Psoriasis Our findings suggest that electrostimulation therapy may offer a promising approach to treating psoriasis and developing wearable devices for its management.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7401682/

What is the effectiveness and adverse event data ... For clinicians: There is no evidence demonstrating the effectiveness of TENS compared to sham TENS, usual care, no treatment, waiting list control or active ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537188/

Transcutaneous Electrical Nerve Stimulation - StatPearls - NCBI A consensus on the efficacy of TENS in pain management has not been achieved, but the tapestry of positive outcomes is evident with prudent ...

5. patents.google.com patents.google.com/patent/US20200297999A1/en

Systems and methods for applying electrical energy to treat ... Although preliminary evidence suggests that the effective electrical stimulation causes neuromodulation, and in particular, causes ANS neuromodulation, it is ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35144946/

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962282700829

Dermatitis from transcutaneous electric nerve stimulation Several dermatologic complications have been associated with the use of this technic, including allergic and irritant contact dermatitis and micropunctate burns ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10818122/

The effect of electrical stimulation on skin vulnerability to ... According to previous studies, the skin beneath electrodes is susceptible to skin contact irritation and allergic reactions. Approximately 40% ...