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Trial registered on ANZCTR


Registration number
ACTRN12616000336482
Ethics application status
Approved
Date submitted
5/02/2016
Date registered
16/03/2016
Date last updated
16/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Shock wave Lithotripsy And mechanical Percussion therapy for lower pole renal calculi (SLAP) trial.
Scientific title
Shock wave Lithotripsy And mechanical Percussion therapy for lower pole renal calculi (SLAP) trial.
Secondary ID [1] 288488 0
None
Universal Trial Number (UTN)
U1111-1179-2671
Trial acronym
SLAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal calculi 297543 0
Condition category
Condition code
Renal and Urogenital 297744 297744 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293847 0
Treatment: Other
Comparator / control treatment
Participants post ESWL for lower pole stones treated with observation alone. Those participants in the control group who still have persistent stone after three months will be offered crossover to the treatment group, with follow up as per the original treatment group.
Control group
Active

Outcomes
Primary outcome [1] 297274 0
Stone free status as assessed by plain X-ray kidney/ureter/bladder (KUB). This will be reviewed by a blinded, independent reviewer.
Timepoint [1] 297274 0
Three months following final ESWL session. For those in the crossover group, final timepoint will be three months from commencement percussion therapy.
Secondary outcome [1] 320551 0
Complication rates - complications of ESWL include haematuria (common), infection, renal or ureteric obstruction (Steinstrasse), perinephric haematoma, retained stone fragments. These will be assessed by interview with completion proforma at each 4 week review, which includes an x-ray KUB.

There are no known complications of percussion therapy other than mild discomfort.
Timepoint [1] 320551 0
Complications will be assessed at each four week review following ESWL. For those in the crossover group, complications will continued to be assessed at each four week review until three months from the commencement of percussion therapy.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified for the trial only after they have been assessed based on standard clinical practice to be suitable for ESWL. Following final ESWL session, participants will be allocated to treatment or control group by the urology nurse using an external randomisation website www.sealedenvelope.com. The urology nurse will not be involved in assessment of outcomes of particpants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by external website
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size requirement was calculated using free access online calculator, using estimates of previous studies. Using an estimated stone-free rate of 50% in MPI group, 20% in observation group (ie 30% difference) with type I error of 0.05 and type II error of 0.2, estimated sample size was 32 in each arm (64 total). Allowing further 10% for withdrawal gives a total sample size of 70 (35 in each group)

Analysis will be performed with intention-to-treat principle. Analysis will be performed using the commercially available ‘statistical package for the social sciences (SPSS)’ program. Chi-square analysis will be used to compare stone-free rates. Multiple regression analysis will be used to analyse and adjust for any confounders.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5235 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 12706 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 292837 0
Self funded/Unfunded
Name [1] 292837 0
Unfunded
Address [1] 292837 0
Unfunded
Country [1] 292837 0
Primary sponsor type
Individual
Name
Jay Roberts
Address
The Prince Charles Hospital
Rode Road
Chermside, Queensland 4032
Country
Australia
Secondary sponsor category [1] 291581 0
None
Name [1] 291581 0
None
Address [1] 291581 0
None
Country [1] 291581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294342 0
The Prince Charles Hospital human research ethics committee
Ethics committee address [1] 294342 0
The Prince Charles Hospital
Human research and ethics committee
Rode Road
Chermside, Queensland 4032
Ethics committee country [1] 294342 0
Australia
Date submitted for ethics approval [1] 294342 0
13/01/2016
Approval date [1] 294342 0
15/01/2016
Ethics approval number [1] 294342 0
HREC/15/QPCH/285

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63338 0
Dr Akshay Kothari
Address 63338 0
The Prince Charles Hospital
Rode Road
Chermside, Queensland 4032
Country 63338 0
Australia
Phone 63338 0
+61731394000
Fax 63338 0
Email 63338 0
akshay.kothari@health.qld.gov.au
Contact person for public queries
Name 63339 0
Dr Jay Roberts
Address 63339 0
The Prince Charles Hospital
Rode Road
Chermside, Queensland 4032
Country 63339 0
Australia
Phone 63339 0
+61731395322
Fax 63339 0
Email 63339 0
jay.roberts@health.qld.gov.au
Contact person for scientific queries
Name 63340 0
Dr Jay Roberts
Address 63340 0
The Prince Charles Hospital
Rode Road
Chermside, Queensland 4032
Country 63340 0
Australia
Phone 63340 0
+61437633858
Fax 63340 0
Email 63340 0
jay.roberts@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results