ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000233820

Ethics application status

Approved

Date submitted

9/02/2012

Date registered

23/02/2012

Date last updated

25/06/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Dermal scarification for the treatment of renal colic.

Scientific title

Dermal scarification versus intramuscular diclofenac sodium injection for the treatment of renal colic. A Prospective Randomised clinical trial.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1127-8773

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Renal Colic

Condition category

Condition code

Renal and Urogenital

Kidney disease

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Endodermal injection (Dermal scarification) of 1ml normal saline at the area of the pain reflection. The injection is administered in participants once only at 8-10 different points intradermally (between the layers of dermis).

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

A single intramuscular injection of 75ml of diclofenac sodium
(Standard treatment). In case of unsuccesful treatment with diclofenac sodium the patients were subjected to dermal scarification. In case of unsuccesful treatment with diclofenac sodium and dermal scarification, the patients were subjected to single IM injection of 50mg Pethidine.

Control group

Active

Outcomes

Primary outcome [1]

Renal colic treatment success with dermal scarification.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.

Timepoint [1]

At five minutes after scarification.

Primary outcome [2]

Renal colic treatment success with diclofenac sodium IM injection.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.

Timepoint [2]

At 45 minutes after IM injection.

Secondary outcome [1]

Patient's ability to locate with accuracy the exact area of the reflection of pain. When the patient can locate with his index finger the max point of pain reflection.

Timepoint [1]

Immediately at presentation.

Secondary outcome [2]

Intensity of pain using a ten-point climax before treatment

Timepoint [2]

Immediately at presentation

Secondary outcome [3]

Intensity of pain using a ten-point climax after treatment with dermal scarification and after treatment with IM injection of Diclofenac Sodium

Timepoint [3]

At five minutes after scarification and at 45 minutes after IM injection of Diclofenac Sodium

Secondary outcome [4]

How fast each method is effective.If there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.

Timepoint [4]

At five minutes after scarification and at 15, 30 and 45 minutes after IM injection of Diclofenac Sodium

Secondary outcome [5]

Duration of pain relief after successful treatment. This is assessed if the decrease in the ten point rating scale is maintained.

Timepoint [5]

At 15, 30, 45, 60 and 120 min after successful treatment

Secondary outcome [6]

In case of unsuccesful treatment with diclofenac sodium, the patients were subjected to dermal scarification. Pain management success.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.

Timepoint [6]

At five minutes after scarification

Secondary outcome [7]

In case of unsuccesful treatment with diclofenac sodium and dermal scarification, the patients were subjected to IM injection of 50mg Pethidine . Pain management success.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.

Timepoint [7]

At 30 minutes after the IM injection

Eligibility

Key inclusion criteria

1. Patients with typical renal or ureteral colic symptoms and at least two laboratory results that justify the diagnosis (haematuria, positive stone shadow at KUB, ultrasonographic dilation of the upper urinary tract at the side of pain).
2. Written consent of the patient’s participation in the study

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Chronic use of analgesic drugs.
2. Use of any analgesic drug during the last 12hours.
3. Use of anticonvulsant during the last 8 hours.
4. Medical history of allergic reaction to NSAIDs.
5. Medical history of stomach ulcer or gastritis.

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)

Numbered containers

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table from a statistic book

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2012

Actual

3/07/2012

Date of last participant enrolment

Anticipated

Actual

4/06/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

210

Accrual to date

Final

Recruitment outside Australia

Country [1]

Greece

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Gennimatas General Hospital of Thessaloniki

Address

41 Ethnikis Aminis, Thessaloniki, 54643

Country

Greece

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Intramuscular injection of non-steroid anti-inflammatory drugs (NSAIDs) is the conventional treatment for renal colic. The most com-monly used NSAID for this purpose is diclofenac sodium. In this study we attempt to investigate the effectiveness of an alternative method in the treatment of renal colic, the endodermal injection (Dermal Scarification) of 1ml normal saline at the area of the pain reflection. This technique is not strictly defined and seems to be based on the principles of acupuncture. The method of application and the success of this treatment were orally transferred from older to younger urologists.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ioannidis Stavros

Address

41 Ethnikis Aminis Street, Thessaloniki, Greece

Country

Greece

Phone

+302310963104

Fax

[email protected]

Contact person for public queries

Name

Kampantais Spyridon

Address

41 Ethnikis Aminis Street, Thessaloniki, 54643

Country

Greece

Phone

+30 6945375525

Fax

[email protected]

Contact person for scientific queries

Name

Kampantais Spyridon

Address

41 Ethnikis Aminis Street, Thessaloniki, 54643

Country

Greece

Phone

+30 6945375525

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Dermal scarification versus intramuscular diclofenac sodium injection for the treatment of renal colic: A prospective randomized clinical trial.	2014	https://dx.doi.org/10.1007/s00240-014-0690-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically