In this study, we investigate the use of lowLevel laser in reducing orchialgia after varicocelectomy. Inclusion criteria include having the consent to participate in the plan; patients aged 18 years and older; at least 12 weeks of their pain; pain before and after varicoscelectomy; ability to work with the treatment group; history of unsuccessful varicocelectomy surgery; and exclusion criteria including patients with Dissatisfaction with participation in the plan; Patients with malignant disease; Epididymitis; Epididymal cysts; Flanker pain; Hydrocele; Neurological defects; Abnormal laboratory findings; Painful varicocele recurrence; Systemic or psychiatric illness; No response to traditional therapies. A randomized clinical trial in patients with orchialgia after varicocelectomy in Shohadaye Tajrish hospitals . 60 patients were randomly divided into three groups with Random numbers (one control group and two intervention group) : 1) Low-Level laser group with a wavelength of 650 nm, 50 mw; 2) Infrared laser (IR) laser group with a wavelength of 820 nm, 100 mW, 3) Laser group off. Patients receive lasers and lasers three times a week for four weeks (12 sessions) each 15 minutes of laser sessions. It should be noted that treatment is done bilaterally. Patients and Doctor-therapist are unaware of laser therapy and silence. Treatment outcome is testicular pain and measured by the unpredictable physician at the end of the study six weeks after the treatment (after the last intervention) and 12 weeks after starting treatment (the last six weeks without intervention).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709278146N23
Registration date:2017-10-15, 1396/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Low Level Laser Therapy in reducing pain after varicocelectomy
Public title
The effect of laser on pain reduction after varicocelectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having consent to participate in the plan; Patients aged 18 years and older; At least 12 weeks have passed from their pain; Before and after varicosculectomy; Ability to co-operate with the treatment group; Failure to successfully complete varicosculectomy; Exclusion criteria: Patients with Dissatisfaction with participation in the plan; Patients with malignant disease; Epididymitis; Epididymal cysts; Flanker pain; Hydrocele; Neurological defects; Abnormal laboratory findings; Painful varicocele recurrence; Systemic or psychiatric illness; No response to traditional therapies;
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2017-09-17, 1396/06/26
Ethics committee reference number
IR.SBMU.REC.1396.110
Health conditions studied
1
Description of health condition studied
orchialgia after varicocelectomy
ICD-10 code
N51.8
ICD-10 code description
Other disorders of male genital organs in diseases classified elsewhere
Primary outcomes
1
Description
The amount of testicular pain
Timepoint
Before treatment,6 week and 12 week after the end of treatment
Method of measurement
McGill questionnaire scoring system and VAS mark
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group 1: Red light-duty laser group with a wavelength of 650 nm, and a power of 50 mW, received three times a week for four weeks (12 sessions) each session for a 15-minute laser.
Category
Treatment - Other
2
Description
Intervention group 2: infrared laser with a wavelength of 820 nm, 100 mW, three times a week for four weeks (12 sessions) each session receive 15 minutes of laser.
Category
Treatment - Other
3
Description
Control group: off laser group. They receive 15 minutes each session three times a week for four weeks (12 sessions).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser Application Research Center in Medical Sciences
Full name of responsible person
Dr.sirus Momenzadeh
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Laser Application Research Center in Medical Science
Full name of responsible person
Dr.Sirus Momenzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Sirus Momenzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Sirus Momenzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)