Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000649415
Ethics application status
Approved
Date submitted
27/02/2016
Date registered
18/05/2016
Date last updated
18/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and safety of pulsed radiofrequency treatment for patients with chronic scrotal pain
Scientific title
In patients complaining of chronic scrotal pain, does pulsed radiofrequency treatment, compared with placebo treatment reduce pain effectively and safely?
Secondary ID [1] 288641 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic scrotal pain 297816 0
Condition category
Condition code
Anaesthesiology 297990 297990 0 0
Pain management
Surgery 297991 297991 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional group: (RF) group: in which pulsed radiofrequency (PRF) is applied on the genital branch of genito-femoral nerve and ilioinguinal nerve using Neurotherm 2000 RF generator. After sterilization of the inguinoscrotal region, we targeted the genital branch of genito-femoral nerve through holding the spermatic cord between the thumb and other fingers, then, 2 ml of lidocaine 1% is infiltrated in the skin at the neck of the scrotum. a 22-gauge 10 cm radiofrequency needle with 10 mm active tip is introduced towards the center of the spermatic cord and repositioned to obtain scrotal pain at 50 HZ and less than 1 volt sensory stimulation. Pulsed radiofrequency is applied for 10 minutes (5 cycles, 2 min each) and finally 5 ml of lidocaine 1 % and 1 ml of 40 mg methyl prednisolone is injected. For the ilioinguinal nerve , under ultrasonographic guidance the ilioinguinal nerve were identified just medial to anterior superior iliac spine, a 22-gauge 10 cm radiofrequency needle with 10 mm active tip is introduced towards the nerve and localization is further confirmed by producing scrotal pain at 50 HZ and less than 1 volt sensory stimulation. Pulsed radiofrequency is applied for 10 minutes (5 cycles, 2 min each) and finally 5 ml of lidocaine 1 % and 1ml of 40 mg methyl prednisolone is injected. The procedure was done by senior staff pain clinician.
Intervention code [1] 294054 0
Treatment: Devices
Comparator / control treatment
Control group: (SHAM) group, the same procedure applied for interventional group is done without giving pulsed radiofrequency and instead of 5 ml of lidocaine 1 % and 1 ml of 40 mg methyl prednisolone, we injected 6 ml of normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 297509 0
change in scrotal pain intensity from baseline assessed by VAS after 1 week of the procedure, reported by pain clinician blinded to the study protocol
Timepoint [1] 297509 0
1 week after the procedure
Secondary outcome [1] 321267 0
analgesics consumption (tryptazole and pregabalin),reported by pain clinician blinded to the study protocol
Timepoint [1] 321267 0
1 week, 1 month, 2 months, 3 months and 6 month post treatment

Eligibility
Key inclusion criteria
1- patients with chronic scrotal pain (orchialgia) lasting more than 3 month after groin surgeries and failed conservative treatment with non-steroidal anti-inflammatory drugs
2- patients that showed satisfactory response to diagnostic spermatic cord block
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1- Patients with other causes of postoperative scrotal pain e.g. epidydmitis, orchitis, and hydrocele
2- Patients on chronic pain killers
3-Patients complaining of groin infection, coagulopathy, psychiatric disorders

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7626 0
Egypt
State/province [1] 7626 0
assuit

Funding & Sponsors
Funding source category [1] 293001 0
Self funded/Unfunded
Name [1] 293001 0
Diab Fuad Hetta
Country [1] 293001 0
Egypt
Primary sponsor type
Individual
Name
Diab Fuad Hetta
Address
South Egypt cancer institute, 2 el Methaque st.,Assiut university,Assiut city,71111,Egypt
Country
Egypt
Secondary sponsor category [1] 291775 0
None
Name [1] 291775 0
none
Address [1] 291775 0
none
Country [1] 291775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294506 0
Ethical comittee of faculty of medicine,Assiut university
Ethics committee address [1] 294506 0
Assiut university, faculty of medicine,10 gamast.,assuit city,71111,egypt
Ethics committee country [1] 294506 0
Egypt
Date submitted for ethics approval [1] 294506 0
10/02/2016
Approval date [1] 294506 0
20/02/2016
Ethics approval number [1] 294506 0
ASSMED2016112

Summary
Brief summary
Chronic post-surgical scrotal pain is frustrating problem for both, patients and clinicians. We offer placebo controlled clinical trial evaluating the efficacy and safety of extended duration pulsed radiofrequency on ilioinguinal and genital branch of genitofemoral nerves in reduction of pain intensity and analgesic needs
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63958 0
Dr Diab Fuad Hetta
Address 63958 0
South Egypt cancer institute, 2 el methaque st.,Assiut university, Assiut city, 71111,Egypt
Country 63958 0
Egypt
Phone 63958 0
+201091090009
Fax 63958 0
Email 63958 0
[email protected]
Contact person for public queries
Name 63959 0
Dr Diab Fuad Hetta
Address 63959 0
South Egypt cancer institute, 2 el methaque st.,Assiut university, Assiut city, 71111,Egypt
Country 63959 0
Egypt
Phone 63959 0
+201091090009
Fax 63959 0
Email 63959 0
[email protected]
Contact person for scientific queries
Name 63960 0
Dr Diab Fuad Hetta
Address 63960 0
South Egypt cancer institute, 2 el methaque st.,Assiut university, Assiut city, 71111,Egypt
Country 63960 0
Egypt
Phone 63960 0
+201091090009
Fax 63960 0
Email 63960 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.