With the aim of the effect of low-level laser therapy on patients with chronic cervical pain, patients referred to the specialized clinic of the hospital with a complaint of chronic neck pain over a period of more than three months who have no red flags (non-specific) are selected if they have tenderness on the spine and Also, they are included in the study if they do not have psychiatric symptoms, including sleep deprivation, and yellow fever, in the age range of 20 to 60 years.All patients are divided into two groups of case and control according to a random number table of 1: 1 ratio. The group assigned to the subject is buried buried in dark envelopes. This envelope will be opened by a doctor only after the initial assessment of each person, and neither patients nor clinical evaluators will be informed of their treatment group. Patients are randomly assigned into two groups of light and off laser, and other therapeutic protocols include exercises of the same patient as exercise and the same medicine. There are 22 patients in each group. In the laser group, using a 980nm low-power laser with a dose 16 Jules per square centimeter in the affected areas of the lining and the muscles of the vertebral column and upper trapezius are exposed 3 times a week for 12 sessions. The results will be evaluated on a weekly basis with a tenderness and painful bedside.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706258146N21
Registration date:2017-08-18, 1396/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-18, 1396/05/27
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
Laser Application Research Center in Medical Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of low level laser therapy for patients with chronic cervical pain (non specific)
Public title
low level laser therapy in cervical pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chronic cervical pain over 3 months without red flags (non-specific); Tenderness on the spine; no symptoms of psychiatry including emotional sleep disorders and yellow fever (yellow flags); ages 20 to 60 Year .
Exclusion criteria: Cranial pain with red flags; Psychopathological symptoms including emotional sleep disorders and yellow flags; over 60 and under the age of 20 years.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Velenjak - Daneshjoo Blvar
City
Tehran
Postal code
Approval date
2016-03-20, 1395/01/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.383
Health conditions studied
1
Description of health condition studied
chronic cervical pain
ICD-10 code
G54.2
ICD-10 code description
Cervical root disorders, not elsewhere classified
Primary outcomes
1
Description
Tenderness and painful motion
Timepoint
Weekly at the beginning and end of treatment
Method of measurement
VAS and DASD questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 980 nm low-power laser with a dose of 16 Jules per square centimeter
Category
Treatment - Other
2
Description
Control group: shame laser, other therapeutic protocols include patient education, exercise and medicine are similar.
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
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences