Percussion Therapy for Kidney Stones

No longer recruiting at 1 trial location

Overseen By Ryan Hsi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Osteoporosis, UTI, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 0-10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether percussion therapy can help clear small leftover kidney stones after surgery. The goal is to determine if a massage device (Massage Percussion Therapy device) can increase the chances of removing these fragments, thereby reducing the need for additional surgeries. Participants will be divided into groups: some will receive percussion therapy immediately after surgery, others at a follow-up appointment, and one group will not receive the therapy. The trial seeks patients who have undergone kidney stone surgery but still have small fragments remaining. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance post-surgical recovery options.

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 prior data suggests that this percussion therapy is safe for kidney stone treatment?

Research shows that percussion therapy can help move kidney stone pieces, making them easier to pass. This therapy uses a device that gently vibrates the kidney area, similar to a massage.

Studies have found that percussion therapy improves the chances of being stone-free after kidney stone surgeries like ureteroscopy. It works well regardless of the device or method used.

Regarding safety, percussion therapy is generally easy to tolerate. It resembles other recovery and performance therapies that use pressure and vibration, which are usually safe and don't cause major side effects.

Overall, percussion therapy appears to be a safe and helpful way to assist in passing kidney stones after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about percussion therapy for kidney stones because it offers a non-invasive approach that could enhance stone clearance without surgery. Unlike standard treatments like extracorporeal shock wave lithotripsy (ESWL) or ureteroscopy, which can be invasive and may require anesthesia, percussion therapy uses a massage-like device to potentially dislodge stones naturally. This method could be particularly appealing as it might reduce recovery time and the need for more invasive procedures, offering a gentler and more patient-friendly option. Additionally, by applying therapy both immediately after surgery and during follow-up appointments, it could maximize the effectiveness of current surgical interventions.

What evidence suggests that percussion therapy is effective for kidney stones?

This trial will evaluate the effectiveness of percussion therapy for kidney stones. Participants may receive percussion therapy in different settings: immediately after surgery in the PACU, during a postoperative appointment, or both. Studies have shown that percussion therapy can help clear kidney stones faster after surgery. Research indicates that this method works well regardless of the technique or device used. One study showed that percussion therapy improved stone removal even when performed at home without a doctor. Another study found that it helps move kidney stone pieces after certain treatments, increasing the chances of being stone-free. Overall, percussion therapy is a promising way to help remove kidney stones after surgery, reducing the need for additional surgeries. ^{1 2 3 5 6}

Who Is on the Research Team?

Ryan Hsi

Principal Investigator

VUMC

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Postoperative appointment percussion Experimental Treatment 1 Intervention

Patient receives percussion therapy in the office on the day of follow up.

Group II: PACU percussion Experimental Treatment 1 Intervention

Patient receives percussion therapy in the PACU immediately after surgery.

Group III: Both PACU and Postop appointment percussion. Experimental Treatment 1 Intervention

Patient receives percussion therapy in the PACU and receives percussion therapy in the office on the day of follow up.

Group IV: Control Active Control 1 Intervention

Patient receives standard postoperative care with no percussion therapy.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Sound stimulation at frequencies of 2.0-3.4 kHz has been shown to effectively aid in the treatment of urolithiasis (kidney stones) in a study involving 544 patients, enhancing the elimination of stone fragments after lithotripsy.

This technique is safe for all patients, as there are no contraindications related to sex, age, or other diseases, making it a promising adjunct to existing lithotripsy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acoustic stimulation of the upper urinary tract in the combined treatment of urolithiasis]. Seregin, SP., Brokhman, SE.[2009]

The third generation lithotripter, Modulith SL, has shown a high disintegration rate of 94% for kidney stones, with 88% of patients being stone-free at follow-up, indicating its efficacy in treating urolithiasis.

This lithotripter is also effective for gallbladder stones (82% success rate) and non-extractable bile duct stones, demonstrating its versatility and ease of use in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulith SL20--development and clinical experience. Köhrmann, KU., Henkel, TO., Potempa, D., et al.[2004]

A systematic review of 60 studies on massage therapy in children found that while many studies did not report adverse events (AEs), 26.6% reported at least one AE, ranging from mild to severe.

Notably, there was a concerning association between abdominal massage and severe AEs, including volvulus in premature infants, which raises safety concerns and suggests caution in using abdominal massage for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with paediatric massage therapy: a systematic review. Karkhaneh, M., Zorzela, L., Jou, H., et al.[2022]

A case report describes a young woman developing severe rhabdomyolysis after using a percussion massage gun, highlighting the potential risks associated with their use, especially in individuals with underlying health conditions like iron deficiency anemia.

The patient required aggressive treatment and recovered well, but this case emphasizes the need for caution and further research on the safety and efficacy of percussion massage guns in both athletes and nonathletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhabdomyolysis After the Use of Percussion Massage Gun: A Case Report. Chen, J., Zhang, F., Chen, H., et al.[2023]

Percussive massage therapy (PMT) significantly improved balance and physical performance in young adults, showing better results than static stretching (SS) in all measured parameters.

Dynamic stretching (DS) also led to significant improvements, but PMT was found to be a more effective alternative for enhancing performance and balance before exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of percussion massage therapy, dynamic stretching, and static stretching on physical performance and balance. Menek, MY., Menek, B.[2023]

A newly constructed laboratory lithotripter effectively crushes kidney stones and gallstones using acoustic shock waves, demonstrating its potential for non-clinical research in lithotripsy.

The device operates at energy levels from 3 to 52 joules, which can be adjusted to optimize stone comminution, and is relatively low-cost at approximately $15,000, making it accessible for research purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental laboratory lithotripter: design, construction, and operation. Akers, SR., Cocks, FH.[2016]

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 71 patients with lower pole renal stones, the use of external physical vibration lithecbole after shock wave lithotripsy significantly improved the stone-free rate to 76.5% compared to 48.6% in the control group, indicating its efficacy in aiding stone clearance.

The treatment group also experienced a much faster mean stone fragment expulsion time of 11.2 minutes versus 9.17 hours in the control group, with no significant difference in complications, suggesting that this method is safe and effective as an adjunctive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Long, Q., Zhang, J., Xu, Z., et al.[2017]

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).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New concepts in shock wave lithotripsy. Weizer, AZ., Zhong, P., Preminger, GM.[2007]

In a study involving 12 patients with residual kidney stone fragments, mechanical percussion combined with inversion therapy and forced diuresis successfully moved stone fragments out of the lower pole of the kidney, as shown by radiographs taken before and after treatment.

The treatment resulted in complete clearance of stone fragments in 8 patients immediately after therapy, and 10 patients passed fragments during the 2-week follow-up, indicating that this method is effective for aiding the passage of kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical percussion inversion can result in relocation of lower pole stone fragments after shock wave lithotripsy. D'a Honey, RJ., Luymes, J., Weir, MJ., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy in the management of stone fragments: progress, status, and needs. Jing, S., Gai, Q., Zhao, X., et al.[2018]

A review of 64,493 adverse reaction reports to the Swedish Medical Products Agency from 1987 to 2006 identified 778 reports related to complementary and alternative medicine (CAM) products, highlighting that these products can cause significant adverse reactions, including serious ones like pulmonary embolism and anaphylaxis.

The most commonly reported CAM substances associated with adverse reactions included Echinacea purpurea and Ginkgo biloba, indicating that while CAM products are popular, they carry risks that warrant further investigation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. Jacobsson, I., Jönsson, AK., Gerdén, B., et al.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05872230

Massage Percussion for Passage of Urolithiasis Fragments ... Percussion therapy is clearly effective to improve stone free rates after ureteroscopy and is effective regardless of technique, protocol, or percussive device.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10987243/

SLAP Trial: Shock Wave Lithotripsy and Mechanical ... This study has shown that MPI can be effectively performed in a home setting without the need for medical supervision and results in improved stone clearance ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05872230/massage-percussion-for-passage-of-urolithiasis-fragments-after-ureteroscopy

Massage Percussion for Passage of Urolithiasis Fragments ... Percussion therapy is clearly effective to improve stone free rates after ureteroscopy and is effective regardless of technique, protocol, or ...

4. withpower.com withpower.com/trial/phase-urolithiasis-6-2023-3ffad

Percussion Therapy for Kidney Stones · Info for Participants Research shows that mechanical percussion, a similar technique, can help move kidney stone fragments after shock wave treatment, improving the chances of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24318643/

Percussion, diuresis, and inversion therapy for the passage ... Percussion, diuresis, and inversion therapy may be safe and effective therapies to assist clearance of lower pole kidney stone fragments following shock wave ...

6. mdpi.com mdpi.com/2411-5142/8/3/138

The Effects of Massage Guns on Performance and Recovery These devices use percussive therapy, achieved by the rapid tip movement, to deliver bursts of pressure/vibration/massage to the myofascial ...