Protocol summary

Summary
Purpose of the study: to determine effect of Lumbar care (based on Back School program) on Caregiver Staffs’ job performance and functional disability in rehabilitation centers of Welfare Organization. This study is a before and after quasi-experimental study in two groups. The subjects in this study include all Caregiver Staffs’ in rehabilitation centers of Welfare Organization in Tehran city that suffering from non-specific chronic low back pain. Sampling: They were selected purposefully (according to inclusion and exclusion criteria) and then randomly divided into intervention and control group. (32 Caregivers in each group) Inclusion criteria: history of back pain for more than three months; VAS ≥ 3; non-specific low back pain; between 18 and 65 years of age Exclusion criteria: pregnancy; back or lumbar spine surgery in the last 2 years Sample size: 32 participants in each group (With confidence coefficient: 95% and With power of test: 80%) Intervention: Back School program (education and exercise) Intervention time: 27/12/2016 the primary outcome or consequences of the study: intensity of pain, functional disability and job performance

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041633474N1
Registration date: 2017-11-05, 1396/08/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Hooshyar Rostami
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6686 0122
Email address
ho.rostami@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor's Office for Research of the University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2016-12-24, 1395/10/04
Expected recruitment end date
2016-12-26, 1395/10/06
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 program) on Caregiver Staffs’ job performance and functional disability in rehabilitation centers of Welfare Organization
Public title
The Effect of Lumbar care (based on Back School program) on job performance and functional disability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of back pain for more than three months; VAS ≥ 3; non-specific low back pain; age between 18 and 65 years old Exclusion criteria: pregnancy; back or lumbar spine surgery in the last 2 years
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, koodakyar Deadlock Alley, Daneshjo Blvd, Tehran City. Tel: (98) - 21 - 222180008 Fax: (98) - 21 - 22180121
City
Tehran
Postal code
1985713834
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
931210004

Health conditions studied

1

Description of health condition studied
Non-specific chronic low back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified

Primary outcomes

1

Description
functional disability
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Rowland and Maurice functional disability inventory

2

Description
Job Performance
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Williams In-Roll Job Performance Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: A two-month curriculum of lumbar care based on Back school program, including information on waist, self-care, establishing and maintaining correct posture and exercises for stability in the waist area. Intervention group participated in a one-hour educational workshop lumbar care based on Back school program, and the training program was followed up and re-educated every two weeks.
Category
Rehabilitation

2

Description
Control group did not receive any treatment plan.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Welfare Services Development Center of Vardavard
Full name of responsible person
Neda Husseinzadeh
Street address
Wardavard Welfare Center, Daropakhsh Street, 17 Kilometers Special Road, Tehran city
City
Tehran

2

Recruitment center
Name of recruitment center
Narmak Welfare Services Center
Full name of responsible person
neda hoseinzadeh
Street address
Narmak Welfare Services Center, Shahid bradaran Bagheri Street, Vali Asr Crossing, East Farjam Street, Square of Mission, Tehran city
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of the University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
MohammadAli Hosseini
Street address
University of Social Welfare and Rehabilitation Sciences, koodakyar Deadlock Alley, Daneshjo Blvd, Tehran City
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 of the University of Social Welfare and Rehabilitation 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
Welfare Organization of Iran
Full name of responsible person
Neda Husseinzadeh
Position
Master science of Physiotherapy- Responsible of physiotherapy unit
Other areas of specialty/work
Street address
Wardavard Welfare Center, Daropakhsh Street, 17 Kilometers Special Road, Tehran city
City
Tehran
Postal code
Phone
+98 21 4431 6913
Fax
+98 21 6686 0122
Email
dptneda_hoseinzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences Tehran/Iran
Full name of responsible person
Mohammadali Hosseini
Position
Associate Professor/ Postdoctoral Fellow of Knowledge Transfer in Cardiac Rehabilitation from UTS, S
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Department of Rehabilitation Management, koodakyar Deadlock Alley, Daneshjo Blvd, Tehran City
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0132
Fax
+98 21 2218 0121
Email
mahmaimy2020@gmail.com
Web page address
www.uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Welfare Organization of Iran
Full name of responsible person
Neda Husseinzadeh
Position
Master science of Physiotherapy/ Responsible of physiotherapy unit
Other areas of specialty/work
Street address
Wardavar Welfare Center, Daropakhsh Street, 17 Kilometers Special Road, Tehran city
City
Tehran
Postal code
Phone
+98 21 4431 6913
Fax
+98 21 6686 0122
Email
dptneda_hoseinzadeh@yahoo.com
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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