Percussion Therapy for Kidney Stones
Recruiting in Palo Alto (17 mi)
Overseen byRyan Hsi
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Must not be taking: Anticoagulants
Disqualifiers: Pregnancy, Osteoporosis, UTI, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
678910How 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.
14111213Eligibility 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 am 18 years old or older.
+1 more
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.
+8 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
References
Modified Mechanical Percussion for Upper Urinary Tract Stone Fragments After Extracorporeal Shock Wave Lithotripsy: A Prospective Multicenter Randomized Controlled Trial. [2018]To investigate the effectiveness of modified mechanical percussion for eliminating upper urinary tract stone fragments after extracorporeal shock wave lithotripsy.
Physical therapy in the management of stone fragments: progress, status, and needs. [2018]With an increased risk of symptomatic events, the complications related to residual fragments are complex and intractable. The management of stone fragments is a challenge to urologists. This review focused on the progress, status, and needs of the newly developed physical therapies to remove fragments and improve the stone-free rate. Physical therapies, including mechanical percussion, diuresis, and inversion therapy, ultrasonic propulsion technology, glue-clot technology, and magnetization technology, will facilitate progress in endoscopic stone fragment retrieval.
New concepts in shock wave lithotripsy. [2007]This monograph reviews the basic principles of shock wave lithotripsy. The focus is on new research on stone fragmentation and tissue injury and how this improved understanding of shock-wave technology is leading to modifications in lithotripsy that will allow this therapy to be a safer, more effective treatment for nephrolithiasis.
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]We evaluate the efficacy and safety of external physical vibration lithecbole in improving the clearance rates of lower pole renal stones after shock wave lithotripsy.
Mechanical percussion inversion can result in relocation of lower pole stone fragments after shock wave lithotripsy. [2019]To determine whether mechanical percussion combined with inversion (MPI) therapy and forced diuresis can move stone fragments out of the lower pole of the kidney.
Effects of percussion massage therapy, dynamic stretching, and static stretching on physical performance and balance. [2023]Percussion massage therapy is a popular approach in sport medicine for physical therapists, but few researchers have investigated the comparison with other intervention methods.
Adverse events associated with paediatric massage therapy: a systematic review. [2022]Massage therapy (MT) is frequently used in children. No study has systematically assessed its safety in children and adolescents. We systematically review adverse events (AEs) associated with paediatric MT.
Rhabdomyolysis After the Use of Percussion Massage Gun: A Case Report. [2023]Percussion massage guns are commonly used by professional athletes and nonathletes worldwide for warm-up and physical recovery; however, there are no published clinical or evidence-based reports on percussion guns regarding their benefits, indications, contraindications, and even side effects. The purpose of this case report is to describe the first case of rhabdomyolysis as a severe and potentially life-threatening illness following use of a percussion gun.
Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. [2009]Although the safety information is limited, use of complementary and alternative medicine (CAM) products is not without risks. Spontaneous reporting systems may be used in the surveillance of these products. We describe the pattern of spontaneously reported CAM related adverse reactions submitted to the Swedish Medical Products Agency (MPA) and highlight areas of safety concern.
Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]Rare, serious, and common, benign adverse events (AE) are associated with MT techniques. A proposed standard for defining AE in manual therapy (MT) practise has been published but it did not include the patient perspective. Research comparing clinician and patient reporting of AE demonstrates that several differences exist; for example, the reporting of objective versus subjective events. The objective of this study was to describe how patients define AE associated with MT techniques. A descriptive qualitative design was employed. Semi-structured interviews were used with a purposive sample of patients (n = 13) receiving MT, from physiotherapy, chiropractic and osteopathic practises in Ontario, Canada. The interview guide was informed by existing evidence and consultation with content and methodological experts. Interviews were audiotaped and transcribed verbatim. Date were analysed by two independent team members using thematic content analysis. A key finding was that patients defined mild, moderate and major AE by pain/symptom severity, functional impact, duration and by ruling out of alternative causes. An overarching theme identified multiple factors that influence how the AE is perceived. These concepts differ from the previously proposed framework for defining AE that did not include the patient perspective. Future processes to create standard definitions or measures should include the patient viewpoint to provide a broader, client-centred foundation.
[Acoustic stimulation of the upper urinary tract in the combined treatment of urolithiasis]. [2009]Sound stimulation of the upper urinary tracts in urolithiasis is validated pathogenetically in experiment and in 544 patients. The highest efficacy has been reached under the sound frequency 2.0-3.4 kHz and diuretic action of herbal decoction in ureteroliths. Under the use of sound waves in the range 2.0-3.4 kHz modulated by low-frequency vibrations good results were obtained in calyculopelvic concrements. In view of faster elimination of concrement fragments as a result of sound stimulation after impulse lithotripsy, the device for sound stimulation would be a useful supplement for lithotripsy units. Sound stimulation is indicated in any uroliths in the absence of obstruction in distal to the stone position. There are no sex-, age- and other disease-related contraindications for the above technique of sound stimulation in urolithiasis.
Modulith SL20--development and clinical experience. [2004]A third generation lithotripter was developed incorporating the advantages of high disintegrative efficacy, anaesthesia-free treatment, combined sonographic and fluoroscopic localization system as well as a multifunctional table for interdisciplinary use. The shock wave generator consists of a cylindrical-shaped electromagnetic coil with a paraboloid reflector. The waves are coupled by means of a water cushion and an impedance adapted foil in which the patient is comfortably positioned. Stones are localized by an in-line ultrasound probe or fluoroscopically by the integrated C-arm. Preclinical trials using the in-vitro stone model demonstrated the superior disintegrative capacity. The in-vivo animal studies evaluated the dose-dependent and reversible kidney trauma, which was comparable to that induced by other lithotripters. The clinical evaluation of the Modulith SL since 1988 was divided into three phases with different technical equipment. It was indicated that sonographic stone localization enables treatment of nearly all kidney stones and 12% of the ureteric calculi. As preference was given to in situ disintegration of all ureteral stones, X-ray targeting became necessary. By increasing the generator voltage in the third phase together with advanced experience, the disintegration rate (94%) was improved. The number of auxiliary measures after ESWL (11%) and treatment time (average 39 min) was decreased. Eighty-eight percent of our patients were stone-free at follow-up. The experience demonstrated that this lithotripter is also easy to handle for gallbladder stones and highly effective (82%) in treatment of endoscopically non-extractable bile duct stones.
Experimental laboratory lithotripter: design, construction, and operation. [2016]A laboratory lithotripter has been constructed and used to comminute (crush to a powder) both kidney stones and gallstones. The stones are placed in the second focus (f2) of an ellipse of revolution whose linear eccentricity is 4.7 cm and then acoustically shocked an average of 200 times by an underwater spark discharge at the first focus (f1). The energy levels available from the capacitors (3 to 52 joules) of this unit extend below and above the range of commercially available clinical devices. The electrical and mechanical design of this unit is presented. At a relatively low cost (approximately $15,000) the unit appears to have considerable application in non-clinical research in lithotripsy. Quantitative results of the application of this device to the comminution of human kidney stones are presented.