Protocol summary

Summary
It was a semi-experimental study; participants were 64 nursing staffs of a hospital. They were selected systematically and then randomly assigned to: intervention (32) and control group (32). Data was collected based on Visual Analogue Scale (VAS) and Roland Morris Disability Questionnaire (RMDQ). Interventional group was received Lumbar care education based on Back school program for 3 hours during an educational workshop and training were followed by pamphlets, but control group only received routine care. Mean score of low back pain and functional disability were measured based on VAS and RMDQ before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015093024277N1
Registration date: 2015-11-25, 1394/09/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
Mehdi Pakbaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7096
Email address
ma.pakbaz@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Lumbar care (based on Back School ) on Nursing Staff’s low back pain and functional disability
Public title
Effect of Back School on low back pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Nursing license, work at hospital in the morning shift during the study, low back pain (based on self-report) Exclusion criteria: Don’t follow the training, having back-surgery within 2 years before, congenital and inflammatory spine disease, pregnancy, severe osteoporosis (based on medical records)
Age
From 24 years old to 58 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple random sampling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd., Evin, Post code: : 1985713834
City
Tehran
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
IR.USWR.REC.1394.151

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

2

Description of health condition studied
Functional Disability
ICD-10 code
Z73.6
ICD-10 code description
Limitation of activities due to disability

Primary outcomes

1

Description
Low back pain
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Visual analogue scale

2

Description
Functional disability
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Rolland-Morris disability questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention was include a lumbar care workshop for intervention group in 3 hours based on back school method.
Category
Prevention

2

Description
control group only received routine care.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-E-Tajrish Hospital
Full name of responsible person
Mrs. Nikpeyma
Street address
Tajrish Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Mehdi Pakbaz
Street address
-
City
-
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mehdi Pakbaz
Position
Student
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd., Evin, Post code: : 1985713834
City
Tehran
Postal code
Phone
+98 51 4622 5334
Fax
Email
ma.pakbaz@uswr.ac.ir; mehdi_pakbaz@live.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
MohammadAli Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd., Evin, Post code: : 1985713834
City
Tehran
Postal code
Phone
+98 21 2218 0136
Fax
Email
mahmaimy2020@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mehdi Pakbaz
Position
Student
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd., Evin, Post code: : 1985713834
City
Tehran
Postal code
Phone
+98 51 4622 5334
Fax
Email
ma.pakbaz@uswr.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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