determination of Comparison of the Efficacy of High Intensity Laser and physiotherapy
Design
Participants will be randomly divided into intervention and control groups (laser and physiotherapy) randomly by 2 envelopes A and B randomly. RCT, single blind, is a randomized clinical trial with a parallel allocation intervention model with the main purpose of treatment.
Settings and conduct
A total review of the subjects is carried out by a physician and physical therapist, followed by subsequent visits to the participants, a questionnaire, a clinical examination and a review of paraclinical measures such as MRI.
Data gathering tools included VAS, Neck Disability Index (NDI) questionnaire,
Neck Pain and Disability Scale (NPDS) and Bournemouth Questioneries.
Participants evaluated by questionnaires in three stages: 1) Pre-treatment 2) Treatment dimension 3) Two weeks later treatment will be done.
All participants in the study will be referred to the Khatam OL Anbiya Clinic.
Participants/Inclusion and exclusion criteria
Having neck pain, job experience, average working hours, age range
Intervention groups
Intervention group: High power laser
Control group: Physiotherapy
Main outcome variables
Neck pain duration, neck pain severity, neck pain, neck pain complications, absenteeism, doctor visit, medication use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190505043483N1
Registration date:2020-04-06, 1399/01/18
Registration timing:retrospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Raheleh Kenareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
y.kenareh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-12, 1398/05/21
Expected recruitment end date
2019-10-13, 1398/07/21
Actual recruitment start date
2019-08-12, 1398/05/21
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2019-11-21, 1398/08/30
Scientific title
Comparison of the Efficacy of High Intensity Laser and physiotherapy in neck area on chronic non-specific pain in office workers
Public title
"The effect of physiotherapy and high power laser on treatment of occupational neck pain"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having neck pain over the past 6 months
Work experience greater than 1 year
Having an average working time of 35 hours and more per week
Age range 25 to 55 years
Exclusion criteria:
Neck and Shoulder Skin Lesions
Pregnancy
Systemic Disease (Neoplasm, Diabetes, Arthritis, Rheumatoid and Neuropathy)
Trauma, Fractures of the spine and diseases of the cervical disc
Driving Accident and Whip Lash Damage
Congenital Disorders of Neck Spine
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocate to two groups. In both ultrasound laser and ultrasound physiotherapy sections, 30 samples will be selected and the control group will be selected as the control group,
After entering the study, participants will be randomly divided into control and intervention groups (laser and physiotherapy) by 2 envelopes A and B based on Random Table. To hide the allocation, the type of intervention specified on the random number table will be written on paper and placed in a sealed envelope in tandem. The executor will execute
Blinding (investigator's opinion)
Single blinded
Blinding description
Before the intervention, the VAS (Visual Analogue Scale) questionnaire will be filled out first and pain intensity will be measured based on the questionnaire score (visual scale measuring pain severity is a 5 cm ruler at the left end of the word without pain and at The right end of the word is the most severe pain word written, depending on the extent of the pain in the past 2 hours, the oncologist signs.
The rest of the questionnaires will also be completed. Participants will then be examined, and the researcher who completes the questionnaire will be assigned to the Blind Study Groups, and will complete the questionnaires immediately after the intervention and two weeks after the intervention.
Participants will be assessed by questionnaires in three stages: 1) pre-treatment 2) post-treatment 3) two weeks after treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadughi University of Medical Sciences
Street address
Faculty of Health, Campus of Medical Sciences, Shohadaye Gomnam Boulevard, Alam Square, Yazd, Iran
City
yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Approval date
2019-08-11, 1398/05/20
Ethics committee reference number
IR.SSU.SPH.REC.1398.058
Health conditions studied
1
Description of health condition studied
Chronic Non-Specific Neck Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of neck pain
Timepoint
Before the intervention and immediately after the intervention and 14 days after the intervention
10 sessions of laser power in 3 times, before intervention, immediately after intervention and two weeks after intervention with VELAS 158 device made in Iran
Category
Rehabilitation
2
Description
10 sessions of physiotherapy in 3 times, before intervention, immediately after intervention and two weeks after intervention with 215p device made in china
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al-Anbia Specialty and Specialty Clinic
Full name of responsible person
Dr. Amideddin Khatibi
Street address
Next to Central Laboratory, Taleghani Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8916657343
Phone
+98 35 3726 3101
Fax
+98 35 3726 3154
Email
clinic@gmail.com
Web page address
http://khatamanbiayazd.ir/portal/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
International Campus Unit, Shahid Sadoughi University of Medical Sciences, 5 kilometers Old Bafgh Road, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Email
info@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Raheleh Kenareh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
chemistry
Street address
Faculty of Health, Campus of Medical Sciences, Shohadaye Gomnam Boulevard, Alam Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Email
y.kenareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Raheleh Kenareh
Position
master Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Health
Street address
Faculty of Health, Campus of Medical Sciences, Shohadaye Gomnam Boulevard, Alam Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Fax
+98 35 3820 9119
Email
y.kenareh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Raheleh Kenareh
Position
Student
Latest degree
Master
Other areas of specialty/work
Occupational Health
Street address
University of Medical Sciences, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Fax
+98 35 3820 9119
Email
y.kenareh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information exist
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available