Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

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

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a TENS device, which uses gentle electrical pulses to relieve pain, on patients who have pain from a ureteral stent after surgery. The goal is to see if it can reduce their pain and nausea, and also lessen the need for narcotic painkillers.

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 data supports the effectiveness of the treatment TENS?

Research shows that long-term use of TENS (transcutaneous electrical nerve stimulation) can reduce pain, decrease the need for pain-related medications, and improve sleep patterns in people with chronic pain. Many patients report continued benefits from TENS, including those with chronic back pain and posttraumatic pain. ^{1 2 3 4 5}

Is TENS generally safe for humans?

Research on adverse events in manual therapy, which includes techniques similar to TENS, shows that while rare serious events can occur, most adverse events are mild and related to pain or symptom severity. It's important to consider patient perspectives on adverse events, as they may differ from clinician reports. ^{6 7 8 9 10}

How is TENS treatment different from other treatments for this condition?

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it uses electrical impulses to relieve pain, which is different from medications that typically involve taking pills or injections. This non-invasive approach can be an alternative for those who prefer not to use drugs or cannot tolerate them. ^{11 12 13 14 15}

Research Team

Simon Conti, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

Interventions

• TENS

Participant Groups

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+

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]

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]

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]

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]

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]

References

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

Long-term transcutaneous electrical nerve stimulation (TENS) use: impact on medication utilization and physical therapy costs. [2019]

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

Transcutaneous electrical nerve stimulation (TENS) treatment outcome in long-term users. [2022]

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

TENS treatment at home: dependence of the efficacy on frequency of use. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Transcutaneous electrical nerve stimulation: its role in the control of chronic pain. [2004]

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

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

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

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]

8. Sweden pubmed.ncbi.nlm.nih.gov

A cluster analysis of serious adverse event reports after human papillomavirus (HPV) vaccination in Danish girls and young women, September 2009 to August 2017. [2022]

9. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]

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

Adverse event reporting in randomised controlled trials of neuropathic pain: considerations for future practice. [2021]

11. Pakistan pubmed.ncbi.nlm.nih.gov

Initiation of Molecular Pathology FCPS in Pakistan Is Urgent! [2022]

12. Pakistan pubmed.ncbi.nlm.nih.gov

Antibiotics versus Surgery for Appendicitis in Pakistan: Has the Former Been the Answer All Along? [2023]

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Digital Morphology: Bridging the Final Gap in Automated Haematology Testing. [2023]

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The Mighty Metabolomics: Emerging Tool for Disease Diagnostics. [2023]

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Eye Muscle Exercises; Solution to Rising Screen Exposure. [2022]