Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001084279
Ethics application status
Approved
Date submitted
14/12/2009
Date registered
18/12/2009
Date last updated
18/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
transcutaneous electrical nerve stimulation (TENS) is beneficial for postoperative pain relief following inguinal hernia repair: a randomized placebo-controlled trial
Scientific title
transcutaneous electrical nerve stimulation (TENS) is beneficial for postoperative pain relief following inguinal hernia repair: a randomized placebo-controlled trial
Secondary ID [1] 1198 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
What is the effect of TENS on postoperative pain and serum cortisol level (SCL) after inguinal hernial repair 252383 0
Condition category
Condition code
Physical Medicine / Rehabilitation 256564 256564 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active TENS group received conventional TENS of 100 Hz, pulse width of 120 microseconds, with perceptible tingling sensation, applied for 30 minutes, twice daily for 5 consecutive days using 2 electrodes that were placed parallel to the incision.
Intervention code [1] 255685 0
Treatment: Devices
Comparator / control treatment
For the placebo TENS group, there was no perceptible sensation, because the TENS unit was switched on to display an active indicator light without any electrical stimulation. the placebo treatment was also applied for 30 minutes, twice daily for 5 consecutive days using 2 electrodes that were placed parallel to the incision
Control group
Placebo

Outcomes
Primary outcome [1] 257454 0
Pain intensity was assessed using visual analogue scale (VAS) and SCL
Timepoint [1] 257454 0
on 5 consecutive postoperative days (PODs), respectively. Follow-up assessment of pain intensity was performed at 30
Primary outcome [2] 257455 0
Pain intensity was assessed using SCL
Timepoint [2] 257455 0
on 5 consecutive postoperative days (PODs), respectively
Secondary outcome [1] 262610 0
nil
Timepoint [1] 262610 0
nil

Eligibility
Key inclusion criteria
The inclusion criteria were: (1) direct or indirect inguinal hernia (Gillbert 1989); (2) use of Lichtenstein surgical technique (Lichtenstien and Shulman 1994); (3) infiltration anesthetic technique (Amid et al 1994); (4)male adult aged between 25 and 45 years; (5) physical status I - II, according to American Assoication of anesthesia (ASA ) (Hamza et al., 1999); (6) no hearing, visual, or speaking impairments; (7) no cognitive disturbances; and (8) resident of Cairo, willing to the participate, with support for postoperative care and a telephone at home for medical assistance, if necessary.
Minimum age
30 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were: (1) morbid obesity; (2) poor liver (serum bilirubin>2.0 mg/dL) or kidneys (serum creatinine>1.5 mg/dL.) (Chiu et al., 1999);(3) neurological or pulmonary diseases;(4) cardiac illness, such as cardiac arrhythmia, angina pectoris, congestive heart failure, and uncontrolled hypertension, and (5) chronic use of opioids (Chiu et al., 1999).

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
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
Not yet recruiting
Date of first participant enrolment
Anticipated
24/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2363 0
Egypt
State/province [1] 2363 0

Funding & Sponsors
Funding source category [1] 256177 0
Self funded/Unfunded
Name [1] 256177 0
Country [1] 256177 0
Primary sponsor type
Individual
Name
mohammed Taher Ahmed Omar
Address
cairo university , faculty of physical therapy cairo egypt
Country
Egypt
Secondary sponsor category [1] 251511 0
Individual
Name [1] 251511 0
Mohammed ahmed El moarsy
Address [1] 251511 0
cairo university , faculty of physical therapy cairo egypt
Country [1] 251511 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258275 0
Materia Teaching Hospital Committee on Human Experimentation (Egypt).
Ethics committee address [1] 258275 0
cairo, egypt Materia Teaching Hospital
Ethics committee country [1] 258275 0
Egypt
Date submitted for ethics approval [1] 258275 0
Approval date [1] 258275 0
08/12/2005
Ethics approval number [1] 258275 0
MTHC2011

Summary
Brief summary
Yet, no study has demonstrated the benefits of TENS in treating postoperative pain after inguinal herniorrhaphy using SCL. The research question for this study were:
1. Does TENS applied for 30 minutes twice daily reduce pain intensity and SCL after inguinal hernia repair ?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30612 0
Address 30612 0
Country 30612 0
Phone 30612 0
Fax 30612 0
Email 30612 0
Contact person for public queries
Name 13859 0
Mohammed taher ahmed
Address 13859 0
faculty of physical therapy , cairo university
Country 13859 0
Egypt
Phone 13859 0
00966542115404
Fax 13859 0
Email 13859 0
[email protected]
Contact person for scientific queries
Name 4787 0
Mohammed taher Ahmed omar
Address 4787 0
faculty of physical therapy , cairo university
Country 4787 0
Egypt
Phone 4787 0
00966542115404
Fax 4787 0
Email 4787 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
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Documents added automatically
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