80 Participants Needed

Percussion Therapy for Kidney Stones

RH
Overseen ByRyan Hsi
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Flexible ureteroscopy is characterized as first-line therapy for renal stones \< 2 cm in size. Stones are commonly treated with dusting or fragmentation techniques which requires passage of stone fragments after surgery. Quoted stone free rate after flexible ureteroscopy is approximately 40-60% with a dusting technique. Residual fragments are often under 1mm in size and can layer in the lower pole of the kidney, complicating spontaneous stone passage. Improving the stone free rate after surgery decreases the need for secondary surgeries and decreases risk of future stone events. Numerous techniques have been proposed to increase stone passage including positional changes and percussion therapy. To date, there is overall limited data a lack of techniques that can be readily available in the outpatient setting, easily added to scheduled appointments, reproducible results and well tolerated by patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on blood thinners (except for low-dose aspirin up to 81mg).

What data supports the effectiveness of the treatment Massage Percussion Therapy device for kidney stones?

Research shows that mechanical percussion, a similar technique, can help move kidney stone fragments after shock wave treatment, improving the chances of clearing the stones.12345

Is percussion therapy generally safe for humans?

There is a case report of a serious condition called rhabdomyolysis (muscle breakdown) occurring after using a percussion massage gun, suggesting potential safety concerns. However, detailed safety data for percussion therapy specifically for kidney stones is not available.678910

How does percussion therapy for kidney stones differ from other treatments?

Percussion therapy for kidney stones is unique because it uses mechanical vibrations to help clear stone fragments after shock wave lithotripsy, which is different from traditional methods that primarily rely on breaking stones with shock waves alone. This approach may enhance the removal of stone fragments, potentially improving treatment outcomes.14111213

Research Team

RH

Ryan Hsi

Principal Investigator

VUMC

Eligibility Criteria

This trial is for adults who can consent and have had ureteroscopy to treat kidney stones, leaving behind tiny fragments. They must be able to undergo percussion therapy and not have conditions like osteoporosis, fluid intake restrictions, untreated UTIs, or need for secondary stone procedures soon.

Inclusion Criteria

You need to have a CT scan of your abdomen before the surgery.
Must be able to give consent
I had kidney stone removal with some tiny stones left.

Exclusion Criteria

I am on blood thinners, but I can take up to 81mg of aspirin.
I am on a doctor-recommended fluid intake restriction.
I have had struvite kidney stones in the past.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy followed by percussion therapy in the PACU and/or during postoperative appointments

0-10 days
1 visit (in-person) for surgery, additional visits for percussion therapy

Follow-up

Participants are monitored for stone passage and any complications, with imaging at six weeks

6 weeks
1 visit (in-person) for follow-up imaging

Treatment Details

Interventions

  • Massage Percussion Therapy device
Trial Overview The study tests a Massage Percussion Therapy device on patients after ureteroscopy to see if it helps pass small kidney stone fragments left in the kidney. The goal is to reduce the need for additional surgeries by increasing the rate of spontaneous stone passage.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Postoperative appointment percussionExperimental Treatment1 Intervention
Patient receives percussion therapy in the office on the day of follow up.
Group II: PACU percussionExperimental Treatment1 Intervention
Patient receives percussion therapy in the PACU immediately after surgery.
Group III: Both PACU and Postop appointment percussion.Experimental Treatment1 Intervention
Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up.
Group IV: ControlActive Control1 Intervention
Patient receives standard postoperative care with no percussion therapy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Findings from Research

Modified mechanical percussion significantly increased the stone-expulsion rate (SER) and reduced the time to first stone expulsion compared to observation, with SERs at 6 hours being 75.4% in the trial group versus lower rates in the control group.
Patients receiving modified mechanical percussion experienced fewer adverse events (42.9% vs. 67.9% in the control group) and required fewer additional interventions, indicating a safer and more effective approach to managing urinary tract stone fragments after shock wave lithotripsy.
Modified Mechanical Percussion for Upper Urinary Tract Stone Fragments After Extracorporeal Shock Wave Lithotripsy: A Prospective Multicenter Randomized Controlled Trial.Jing, S., Liu, B., Lan, W., et al.[2018]
New physical therapies, such as ultrasonic propulsion and glue-clot technology, are being developed to improve the removal of kidney stone fragments, which is a significant challenge for urologists.
These innovative techniques aim to enhance the stone-free rate after procedures, addressing the complications associated with residual stone fragments and potentially reducing the risk of symptomatic events.
Physical therapy in the management of stone fragments: progress, status, and needs.Jing, S., Gai, Q., Zhao, X., et al.[2018]
Recent research on shock wave lithotripsy has enhanced our understanding of how shock waves fragment kidney stones and affect surrounding tissue, leading to improvements in the technique.
These advancements aim to make shock wave lithotripsy a safer and more effective treatment option for patients with kidney stones (nephrolithiasis).
New concepts in shock wave lithotripsy.Weizer, AZ., Zhong, P., Preminger, GM.[2007]

References

Modified Mechanical Percussion for Upper Urinary Tract Stone Fragments After Extracorporeal Shock Wave Lithotripsy: A Prospective Multicenter Randomized Controlled Trial. [2018]
Physical therapy in the management of stone fragments: progress, status, and needs. [2018]
New concepts in shock wave lithotripsy. [2007]
A Prospective Randomized Controlled Trial of the Efficacy of External Physical Vibration Lithecbole after Extracorporeal Shock Wave Lithotripsy for a Lower Pole Renal Stone Less Than 2 cm. [2017]
Mechanical percussion inversion can result in relocation of lower pole stone fragments after shock wave lithotripsy. [2019]
Effects of percussion massage therapy, dynamic stretching, and static stretching on physical performance and balance. [2023]
Adverse events associated with paediatric massage therapy: a systematic review. [2022]
Rhabdomyolysis After the Use of Percussion Massage Gun: A Case Report. [2023]
Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. [2009]
Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]
11.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Acoustic stimulation of the upper urinary tract in the combined treatment of urolithiasis]. [2009]
Modulith SL20--development and clinical experience. [2004]
13.United Statespubmed.ncbi.nlm.nih.gov
Experimental laboratory lithotripter: design, construction, and operation. [2016]
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