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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]

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

Kidney Stones

Urolithiasis

Condition category

Condition code

Emergency medicine

Other emergency care

Anaesthesiology

Pain management

Renal and Urogenital

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]

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]

Change in pain as assessed by Wong Baker FACES,.

Timepoint [1]

The primary time point will 0, 15, 30, 45 and 60 minutes (primary endpoint) after randomiztion

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Angliss Hospital - Upper Ferntree Gully

Recruitment postcode(s) [1]

3156 - Upper Ferntree Gully

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Special Purpose Fund Emergency Department Angliss Hospital

Address [1]

Emergency Department
Angliss Hospital
Albert Street
Upper Ferntree Gully
VIC 3156

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Eastern Health Ethics Board

Ethics committee address [1]

Eastern Health
5 Arnold Street
Box Hill
VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/03/2018

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Background: Kidney stones are a common presentation to Emergency Departments throughout Australasia, with a lifetime prevalence of 10 to 15%. The main aim of management in the ED is to provide fast, effective and safe analgesia to patients. The most commonly prescribed analgesia in renal colic are non steroidal anti-inflammatory drugs(NSAIDS), opioids and paracetamol. TENS has been used to complement traditional analgesia in both labour and postoperative pain control.

Hypothesis: Patients with renal stones using transcutaneous electrical nerve stimulation (TENS) experience the same amount of pain as well as requiring similar doses of pharmacological analgesia compared with patients not using transcutaneous electrical nerve stimulation who present to the Angliss Emergency Department
Methods: This is a prospective randomised control study aiming to study 2 arms of patients – with and without the use of TENS equipment as an adjunct in the management of pain associated with renal colic.
Significance: The research undertaken will help understand help a better understanding of the analgesic options available to patients suffering renal colic who present to the emergency department. This will help medical practitioners explore options to better manage the pain associated with renal colic and complement with a potential decrease in the use of opioid prescription of pharmacotherapy. Furthermore if successful in the emergency department, then there is potential for TENS to be used in the community as an adjunct for patients to better manage their pain in regards to renal colic.

Trial website

Trial related presentations / publications

Public notes

References
1.	Fisang C, Anding R, Muller SC, et al Urolithiasis—an interdisciplinary diagnostic, therapeutic and secondary preventive challenge. Deutsches Arzteblattinternational 2015;112(6): 83-91. DOI:10.3238/arztebl 2015.0083[published Online First :2015/02/28]
2.	Ghani KR, Roghmann F, Sammon JD, et al Emergency department visits in the United States for upper urinary tract stones: trends in hospitalization and charges. The Journal of urology 2014;91(1):90-6.  DOI: 10.1016/j.juro.2013.07.098[published Online First:2013/08/13]
3.	Pickard R, Starr K, MacLennan G, et.al Use of drug therapy in management of symptomatic ureteric stones in  hospitalised adults: a multicentre, placebo-controlled, randomised control trial and cost effectiveness analysis of a calcium channel blocker(nifedipine) and an alpha -blocker( Tamsulosin) (the SUSPEND trial). Health technology assessment (Winchester , England) 2015;19(63):vii-viii, 1-171.  DOI: 10.3310/hta19630 [published Online First: 2015/08/06]
4.	Afshar K, Jafari S, Marks AJ, et al. Non-steroidal anti-inflammatory drugs(NSAIDS) and non-opoids for acute renal colic. The Cochrane database of systematic reviews 2005(2):Cd004137.  DOI: 10.1002/14651858.CD004137.pub3 [published Online First: 2005/04/23]
5.	Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain management in labour. Cochrane Database of Systematic Reviews 2009, Issue 2 Art, No.: CD007214. DOI: 10.1002/14651858.CD007214.pub2.
6.	Bjordal, J.M., Johnson, M. I. and Ljunggreen, A.E. (2003), Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative e analgesic consumption. A meta analysis of optimal treatment parameters for postoperative pain. European Journal of Pain, 7:181-188. DOI:10.1016/S1090-3801(02)00098-8
7.	Mora B., Giorni E., Dobrovits M., Barker R., Lang T., Gore C. and Kober A. (2006), Transcutaneous electrical nerve stimulation: An Effective Treatment for Pain Caused by Renal Colic in Emergency Care. The Journal of Urology (2006), Issue 5, Volume 175 : 1737-1741. DOI:10.1016/S0022-5347(05)00980-8.
8.	Garra G., Singer AJ., Domingo A., Thode HC Jr. (2013) The Wong-Baker pain FACES scales of measure of pain, not fear. Pediatric Emergency Care 2013 Jan 29(1):17-20. DOI 10.1097/PEC.0b013e31827b2299
9.	Mehendele AW., Goldman MP., Mehendele RP., (2013) Opioid overuse pain syndrome: the story of opioids, Prometheus unbound. J Opioid Management 2013 Nov- Dec, 9(6): 412-438.  DOI 10.5055/jom 2013.0185

Contacts

Principal investigator

Name

Dr Umadevan Rajasagaram

Address

Emergency Department
Angliss Hospital
Albert Street
Upper Ferntree Gully
VIC 3156

Country

Australia

Phone

(+613)97591940

Fax

(+613)97591930

umadevan.rajasagaram@easternhealth.org.au

Contact person for public queries

Name

Umadevan Rajasagaram

Address

Emergency Department
Angliss Hospital
Albert Street
Upper Ferntree Gully
VIC 3156

Country

Australia

Phone

(+613)97591940

Fax

(+613)97591930

umadevan.rajasagaram@easternhealth.org.au

Contact person for scientific queries

Name

Umadevan Rajasagaram

Address

Emergency Department
Albert Street
Angliss Hospital
Upper Ferntree Gully
VIC 3156

Country

Australia

Phone

(+613)97591940

Fax

(+613)97591930

umadevan.rajasagaram@easternhealth.org.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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