Protocol summary

Summary
The aim of this study is to determine the role of exercise protocol in the treatment of low back pain in a specialized clinic; Both in terms of intensity of pain and disability caused by the disorder. The population of this study is all of the patients with back pain in the city of Hamedan. Among those, with available sampling method and according to previous studies, 15 subjects will be selected as sample. Inclusion criteria is medical diagnosis. Exclusion criteria is personal dissatisfaction or having another chronic mental or physical illness that are asked in the form of a general question. Before the intervention, a pre-test is taken. Designed intervention (exercise protocol) will take 6 weeks and three sessions per week and each session lasts for 45 minutes. After the intervention, post-test is taken. The intervention outcomes is including of decrease of pain and disability in patients with low back pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100230066N1
Registration date: 2017-02-18, 1395/11/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-18, 1395/11/30
Registrant information
Name
Mohammad Babamiri
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0398
Email address
m.babamiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research and technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEvaluation the role of exercise protocol in reduction of pain and disability in patients with low back pain
Public title
effect of exercise on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Medical diagnosis; Having back pain; Individual satisfaction Exclusion criteria: The lack of personal satisfaction in each of the stages; having another Simultaneous chronic mental or physical illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Opposite of Mardom Park, Ghaem Boulevard, Mahdiya, Hamadan
City
Hamadan
Postal code
6517838736
Approval date
2016-09-17, 1395/06/27
Ethics committee reference number
IR.UMSHA.REC.1395.281

Health conditions studied

1

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

Primary outcomes

1

Description
back pain
Timepoint
45 days after intervention
Method of measurement
by questionnaire

2

Description
disability
Timepoint
45 days after intervention
Method of measurement
by questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Specific exercise protocol used, according to the specialist. The protocol is designed to impact on pain and disabilities caused by back pain will be trained.This is an exercise program design: for 6 weeks and three sessions per week and each session lasts for 45 minutes. During this time, one must do the exercise movements that are planned. exercises designed to reform the general movements and improve of muscle forces that are involved.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikhol Rais Clinic
Full name of responsible person
Rashid Haydari Moghadam
Street address
First floor, Avicenna Clinic, Four-way Khajeh Rashid
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Manoochehr Karami
Street address
Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical 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
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Babamiri
Position
Assistant Professor, Ph.D
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Boulevard, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0398
Fax
Email
m.babamiri@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Rashid Haydari Moghadam
Position
Ph.D of exercise physiology
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Boulevard, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0398
Fax
Email
dr_haydari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Babamiri
Position
Assistant Professor, Ph.D
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmide Boulevard, Hamadan
City
Hamadan
Postal code
Phone
00
Fax
Email
m.babamiri@umsha.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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