41 Participants Needed

Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

C
Overseen ByConti
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1112131415

Research Team

SC

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).
See 6 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: TENS deviceExperimental Treatment1 Intervention
Participants will use the TENS device until the ureteral stent is removed
Group II: Standard careActive Control1 Intervention
Participants will follow standard care until the ureteral stent is removed

Find a Clinic Near You

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

References

Long-term transcutaneous electrical nerve stimulation (TENS) use: impact on medication utilization and physical therapy costs. [2019]
Transcutaneous electrical nerve stimulation (TENS) treatment outcome in long-term users. [2022]
TENS treatment at home: dependence of the efficacy on frequency of use. [2019]
Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain. [2022]
Transcutaneous electrical nerve stimulation: its role in the control of chronic pain. [2004]
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]
Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]
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]
Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Adverse event reporting in randomised controlled trials of neuropathic pain: considerations for future practice. [2021]
Initiation of Molecular Pathology FCPS in Pakistan Is Urgent! [2022]
Antibiotics versus Surgery for Appendicitis in Pakistan: Has the Former Been the Answer All Along? [2023]
Digital Morphology: Bridging the Final Gap in Automated Haematology Testing. [2023]
The Mighty Metabolomics: Emerging Tool for Disease Diagnostics. [2023]
Eye Muscle Exercises; Solution to Rising Screen Exposure. [2022]