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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment TENS for reducing pain?

Research shows that TENS, which uses mild electrical currents to relieve pain, is effective in reducing pain for various conditions like chronic back pain and other pain syndromes. This suggests it might also help with pain from psoriasis injections. ^{1 2 3 4 5}

Is TENS therapy safe for humans?

TENS therapy, which uses low voltage electrical currents on the skin, is generally considered safe for treating various pain conditions, with studies showing it is well-tolerated by patients. ^{3 4 5 6 7}

How does TENS differ from other treatments for psoriasis injection pain?

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it uses low voltage electrical currents applied to the skin to relieve pain, making it a non-drug option compared to traditional pain medications. This method is particularly novel for psoriasis injection pain, as it offers a non-invasive way to manage discomfort without the side effects associated with drugs. ^{3 5 6 8 9}

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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Does transcutaneous electrical nerve stimulation affect pain, neuropathic pain, and sympathetic skin responses in the treatment of chronic low back pain? A randomized, placebo-controlled study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain. [2022]

3. England 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). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of pain treatment with electrostimulation: a study on TENS in patients with different pain syndromes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of chronic pain: predictive factors and evaluation of the method. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]

9. Netherlands 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. [2022]