Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000462280p
Ethics application status
Submitted, not yet approved
Date submitted
13/03/2018
Date registered
29/03/2018
Date last updated
29/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
This Study intends to study the pain relief potential of transcutaneous electrical nerve stimulation (TENS) machines in people suffering from kidney stones.
Scientific title
Suppression of pain in renal stones using transcutaneous electrical nerve stimulation (TENS) in patients with renal calculi.
Secondary ID [1] 294454 0
Nil known
Universal Trial Number (UTN)
U 1111-1210-8794
Trial acronym
SUPER 10- SUppression of Pain in Renal stones using TENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Colic 307043 0
Kidney Stones 307124 0
Urolithiasis 307125 0
Condition category
Condition code
Emergency medicine 306143 306143 0 0
Other emergency care
Anaesthesiology 306238 306238 0 0
Pain management
Renal and Urogenital 306239 306239 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will be conducted in the Emergency department at the Angliss Hospital. The patients will be unaware of which arm of the trial they are in. The TENS machine will be applied by a consultant emergency physician with at greater 7 years’ experience
In the active arm (Group B -which will be the even numbers in the randomization sequence)) there will be placement of 4 electrodes (2 in parallel) over the topical site of the affected kidney ( Lt or Rt flank - over L1 to L4 area), and the output TENS will be increased until the patient feels muscle contraction (this will be individualised to each patient- the usual range of TENS is 15 to 35mA) and then reduce the output until the patient feels comfortable. This will be individualised to each patient to ensure each patient receives the optimal therapy from the TENS machine. The placement and the dosage of the TENS machine including the incremental increase of voltage will be done by specialist emergency physicians who are at least 7 years in experience). The duration of the active arm will be for exactly 60 mins with a timer present on the TENS machine and the machine will automatically switch off at the 60 minute mark. The TENS therapy will be administered only once in a single session.

Strategies used to monitor adherence includes direct supervision as this trial will be conducted in a Emergency ward or Emergency Department. Furthermore since the placement of the pads is on the back of the patient there is limited ability of the patient to to remove pads without assistance. The TENS machine is set up at the start of the trial and once activated is locked , thereby making it difficult to be tampered with. There will be 15 minutely checks on the patient for the duration of the hour to ensure that the patient is still experiencing the sensation from the TENS machine.
Intervention code [1] 300631 0
Treatment: Devices
Comparator / control treatment
The two arms of the trial consist of a control group (Group A – which will be the odd numbers in the randomisation sequence) which has the TENS machine and the electrodes attached on the flank where the renal calculi have been identified .The output on the TENS machine will then be increased to a maximum of 2 mA's (placebo). The placement and the dosage of the TENS machine including the incremental increase of voltage will be done by specialist emergency physicians who are at least 7 years in experience).

Strategies to monitor adherence will be similar as the active arm.
Control group
Placebo

Outcomes
Primary outcome [1] 305158 0
Change in pain as assessed by Wong Baker FACES,.
Timepoint [1] 305158 0
The primary time point will 0, 15, 30, 45 and 60 minutes (primary endpoint) after randomiztion
Secondary outcome [1] 344363 0
The patients will be asked at the end of the treatment to complete a 4 point satisfaction survey which includes the options of -
(a) strongly disagree
(b) disagree
(c) agree
(d) strongly agree

These questions will include the following

(1) I have less pain at the end of treatment
(2) I like the idea of using non drug pain relief
(3) I would have used more pain medications if I did not have TENS in the last 60 minutes
(4) If I have pain from kidney stones again, I would request to use TENS in conjunction with pain medication
Timepoint [1] 344363 0
1 hour after randmoization

Eligibility
Key inclusion criteria
Patients aged between 18 and 65 with confirmed renal stones
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under the age of 18 or over 65.
Patients with a high degree of ureteric obstruction.
Patients requiring imminent surgical intervention.
Patients unable to provide informed consent

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)
The trial will be conducted in the Emergency department at the Angliss Hospital. The patients who agree to participate will then be sequentially randomly assigned to either the control arm or the treatment arm of the trial using a random number generator application (Pretty Random AppR). The information will be sealed in a numbered sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
I intend to contract a biostatistician to calculate, if there is a statistical significance in the degree of pain as well as the type and dosage of pharmacotherapy used in the arms of the trial. I aim to identify and compare the median as well the 25th and 75th quartile using box plots of the frequency of pain relief within the 60 minutes experienced between the 2 arms and to ascertain a correlation.

Furthermore I intend to compare the median as well the 25th and 75th quartile using box plots for the questions posted at the end of the survey.
1. I have less pain at the end of the treatment
2. I like the idea of using non-drug pain relief
3. I would have used more pain medications if I did not have TENS in the last 60 minutes
4. If I have pain from kidney stones again, I would request to use TENS in conjunction with pain medication.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2018
Actual
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10379 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 22057 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 298969 0
Hospital
Name [1] 298969 0
Special Purpose Fund Emergency Department Angliss Hospital
Country [1] 298969 0
Australia
Primary sponsor type
Individual
Name
Umadevan Rajasagaram
Address
Emergency Department
Angliss Hospital
Albert Street
Upper Ferntree Gully
VIC 3156
Country
Australia
Secondary sponsor category [1] 298191 0
None
Name [1] 298191 0
None
Address [1] 298191 0
None
Country [1] 298191 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299901 0
Eastern Health Ethics Board
Ethics committee address [1] 299901 0
Ethics committee country [1] 299901 0
Australia
Date submitted for ethics approval [1] 299901 0
29/03/2018
Approval date [1] 299901 0
Ethics approval number [1] 299901 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81926 0
Dr Umadevan Rajasagaram
Address 81926 0
Emergency Department
Angliss Hospital
Albert Street
Upper Ferntree Gully
VIC 3156
Country 81926 0
Australia
Phone 81926 0
(+613)97591940
Fax 81926 0
(+613)97591930
Email 81926 0
[email protected]
Contact person for public queries
Name 81927 0
Umadevan Rajasagaram
Address 81927 0
Emergency Department
Angliss Hospital
Albert Street
Upper Ferntree Gully
VIC 3156
Country 81927 0
Australia
Phone 81927 0
(+613)97591940
Fax 81927 0
(+613)97591930
Email 81927 0
[email protected]
Contact person for scientific queries
Name 81928 0
Umadevan Rajasagaram
Address 81928 0
Emergency Department
Albert Street
Angliss Hospital
Upper Ferntree Gully
VIC 3156
Country 81928 0
Australia
Phone 81928 0
(+613)97591940
Fax 81928 0
(+613)97591930
Email 81928 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.