TENS for Pain After Kidney Stone Surgery

Overseen By Conti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Children, Pregnant, Epilepsy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called a TENS unit (Transcutaneous Electrical Nerve Stimulation) to determine its effectiveness in reducing pain and nausea after kidney stone surgery. The device offers a non-drug option to manage discomfort from a stent placed in the ureter (the tube connecting the kidney to the bladder) after the procedure. The trial also aims to assess whether using this device can reduce the need for pain medications. Individuals who have undergone kidney stone surgery and have a stent afterward might be suitable for this study. As an unphased trial, this study provides participants with the opportunity to explore a non-drug pain management option that could enhance recovery and reduce reliance on medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TENS device is safe for treating ureteral stent pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe. TENS uses gentle electrical pulses to reduce pain. Studies have found it effective and well-tolerated for many conditions. Importantly, no reports of serious side effects have emerged from using TENS. People often experience less pain during or immediately after its use compared to a placebo. This suggests that TENS could be a reliable and safe method for managing pain without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TENS device for pain control after ureteroscopy because it offers a non-drug approach to managing pain. Unlike traditional pain medications, which can have side effects like drowsiness or dependency, TENS (Transcutaneous Electrical Nerve Stimulation) works by sending electrical impulses through the skin to disrupt pain signals without drugs. This method could potentially reduce the need for pharmaceuticals, making recovery smoother and safer for patients.

What evidence suggests that the TENS device is effective for reducing ureteral stent pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) can reduce pain and lessen the need for pain medications. Studies have found that TENS lowers pain levels during or immediately after use without causing serious side effects. Users of TENS devices reported feeling better and needing less pain medication. In this trial, one group of participants will use the TENS device to manage pain and other symptoms associated with ureteral stents, while another group will follow standard care. Overall, TENS appears to be a promising non-drug option for easing pain after ureteroscopy. ^{1 3 5 6 7}

Who Is on the Research Team?

Simon Conti, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients receiving a stent following their ureteroscopy and laser lithotripsy

You are an adult patient who will be receiving standard treatment for urinary stone disease, which involves ureteroscopy and laser lithotripsy.

Exclusion Criteria

Patients unable to answer pain questionnaire

You are pregnant.

You are currently undergoing a procedure called percutaneous nephrolithotomy (PCNL).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the TENS device or follow standard care until the ureteral stent is removed

3-10 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TENS

How Is the Trial Designed?

Group I: TENS device Experimental Treatment 1 Intervention

Participants will use the TENS device until the ureteral stent is removed

Group II: Standard care Active Control 1 Intervention

Participants will follow standard care until the ureteral stent is removed

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

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]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

In a study of 846 patients with chronic posttraumatic pain, particularly back pain, long-term use of transcutaneous electrical nerve stimulation (TENS) resulted in 44.6% of patients being free of disability and 36.2% able to perform modified work.

At a six-month follow-up, 83.8% of respondents reported continued benefits from TENS, including significant pain reduction and decreased medication use, suggesting that TENS provides lasting therapeutic effects beyond a placebo response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation: its role in the control of chronic pain. Fried, T., Johnson, R., McCracken, W.[2004]

Citations

1. journals.lww.com journals.lww.com/auajuro/fulltext/2024/05001/mp26_06_treatment_of_ureteral_stent_related.863.aspx

mp26-06 treatment of ureteral stent-related symptoms with ... CONCLUSIONS: While patients who received a TENS device reported subjective improvement of their symptoms and decreased pain medication use, ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/29/NCT05153629/Prot_SAP_000.pdf

Noninvasive Electrical Stimulator as an Adjunct for Pain ... Despite the benefits of placing a stent post-ureteroscopy, eighty percent of patients with ureteral stents complain of a various side effect ...

3. withpower.com withpower.com/trial/phase-kidney-calculi-11-2021-1455f

Noninvasive Electrical Stimulator as a Pain Control ... Research shows that long-term use of TENS (transcutaneous electrical nerve stimulation) can reduce pain, decrease the need for pain-related medications, and ...

4. 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.

5. researchgate.net researchgate.net/publication/301720734_Ureteral_Stent-Associated_Pain_A_Review

Ureteral Stent-Associated Pain: A Review | Request PDF ... Numerous studies have documented symptoms associated with their use, including urinary frequency, urgency, dysuria, incontinence, hematuria, ...

6. academic.oup.com academic.oup.com/book/24860/chapter/188568725

Contraindications, precautions, and adverse events It should be safe to use conventional TENS in individuals to improve wound healing and reduce claudication with arterial disease. However, the Canadian ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05153629

Noninvasive Electrical Stimulator as a Pain Control ... The primary aim for the investigators is to determine if use of a TENS unit will reduce post-operative pain and nausea associated with the ureteral stent.