The purpose of this study is to survey Cranio sacral therapy on therapeutic touch on chronic low back pain in nurses. All nurses working in the clinical departments of Kashan Shahid Beheshti Hospital, who have criteria for entering the study, will be divided into two groups: intervention and control. First, The samples will complete the McGill questionnaire, then in the test group, Cranio Sacrarl Therapy will be performed for 8 weeks and weekly 2 sessions. The control group will receive no treatment in the same time period. Then, the intensity of pain will be measured immediately and one month after the intervention. In the end, the two groups will be compared
Design
Intervention
Settings and conduct
A sample of 60 subjects who have entered the study and who are working in the clinical units of the hospital will be in control and test groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have non specific chronic low back pain; have not damage in low back pain; have complete satisfaction to participate in the study; have Score 4 or higher than the visual scale of the pain; clinical activity in each department of the hospital.
Exclusion criteria: using analgesics for low back pain during the study; unwilling to participate in the study; missing more than two sessions; use of other complementary therapies during study.
Intervention groups
Cranio Sacral Therapy will perform two day a week for 8 weeks in intervention and nothing in control group.
Main outcome variables
Severity of Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N37
Registration date:2018-05-02, 1397/02/12
Registration timing:registered_while_recruiting
Last update:2018-05-02, 1397/02/12
Update count:0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-25, 1397/02/05
Expected recruitment end date
2018-07-27, 1397/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Therapeutic Touch with the method Cranio Sacral Therapy on the severity of Chronic Low Back Pain in Nurses
Public title
Effect of Therapeutic Touch with the method CranioSacral Therapy on the Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have non Specific low back pain
Have not Injury in low back
Have Complete Satisfaction to participate in the study
Have clinical activity
Have a Score higher than 4 of the visual Analog Scale
Exclusion criteria:
Pregnancy
Use of other Complementary therapies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of test and Control groups is done using quadratic random blocks method using software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی کاشان
Street address
Kashan,Ravand Street,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.36
Health conditions studied
1
Description of health condition studied
Cranio Sacral Therapy
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Severity of Pain
Timepoint
Before,After and 1 month After intervention
Method of measurement
Mac Gill questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, Cranio Sacral Therapy will perform two day a week for 8 weeks.
Category
Treatment - Other
2
Description
in the Control group, no intervention will not perform during 8 weeks
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinical Wards in Kashan Shahid Beheshti Hospital
Full name of responsible person
Neda Mirbagher
Street address
Kashan,Ravand street,Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Kashan,Ravand Street,Kashan University Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,RavandStreet,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,Ravand street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,Ravand Street,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
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
Confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available