None listed
Conditions
Brief summary
The aim of this study is to compare manual percussion and inversion therapy with observation alone to see if this therapy does improve the rate of stone clearance. To date there have only been two randomised trials to assess mechanical percussion and inversion therapy. Although both these studies show promising results, pooling data has some problems as the treatment methodology was also different in each study, with one study enrolling participants immediately and the other enrolling only those with persisting stone at three months. Also in both of these studies, treatment was given in the clinic and administered by staff. Many institutions do not have such resources, therefore the aim of this study is to see if the previous results could be replicated with percussion therapy administered in the home setting.
Interventions
Mechanical percussion therapy post extracorporeal shockwave lithotripst (ESWL) for lower pole kidney stones vs observation alone.
ESWL will be performed under general anaesthesia as per standard practice. Details of treatment such as number of shocks, intensity, and any difficulties or immediate complications will be recorded. Following ESWL participants will be randomly allocated to perform percussion therapy or control group.
For the percussion therapy participants will need to place thems
Mechanical percussion therapy post extracorporeal shockwave lithotripst (ESWL) for lower pole kidney stones vs observation alone. ESWL will be performed under general anaesthesia as per standard practice. Details of treatment such as number of shocks, intensity, and any difficulties or immediate complications will be recorded. Following ESWL participants will be randomly allocated to perform percussion therapy or control group. For the percussion therapy participants will need to place themself in an inverted position. You may do this with an inclined surface or by leaning over a piece of furniture with some pillows to support your upper body. A friend or family member will be required to assist with the percussion, with an open hand, the person assisting should strike the back over the kidney which had the stone treated. The amount of force required is similar to that of a firm massage. The strike should be firm enough that the participant can feel a vibration through your body, though not so firm that it causes pain or bruising. Following a 5-10min training with the urology nurse and provision of written information treatments are to commence 1 week after ESWL and be performed for approx 10minutes, 5days per week. Treatments will continue for three months. Participants will be provided with a questionaire to record the treatments performed and details.
Sponsors
Jay Roberts
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will have lower pole stones 5-15mm who are already scheduled to receive ESWL independent of this trial. Participants will be identified for the trial only after they have been assessed based on standard clinical practice to be suitable for ESWL.
Exclusion criteria
1. Anatomical abnormalities including horseshoe kidney, fragments in calyceal diverticulum, infundibular stenosis, pelvo-ureteric junction obstruction, or ureteric stricture 2. Contraindications to ESWL including abdominal aortic aneurysm, anticoagulant or antiplatelet treatment unable to be safely stopped peri-ESWL. 3. Radiolucent calculi including uric acid stones 4. Presence of ureteric stent 5. Medical conditions which might make inversion dangerous including morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, significant coronary artery disease, symptomatic gastro-oesophageal reflux 6. Previous treatment for same stone within last three months.
Outcome results
None listed