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This Study intends to study the pain relief potential of transcutaneous electrical nerve stimulation (TENS) machines in people suffering from kidney stones.

Suppression of pain in renal stones using transcutaneous electrical nerve stimulation (TENS) in patients with renal calculi.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000462280
Acronym
SUPER 10- SUppression of Pain in Renal stones using TENS
Enrollment
34
Registered
2018-03-29
Start date
2018-04-01
Completion date
2018-09-30
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 outpu

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.

Sponsors

Umadevan Rajasagaram
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients aged between 18 and 65 with confirmed renal stones

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

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 9, 2026