Effect of tailored internet-based intervention in patient with non specific persistent low back pain :A randomized control trial.
The 81 patient with non specific persistent low back pain with Inclusion criteria: 18 – 65 years old. non-specific low back pain (more than 6 weeks) and Exclusion criteria: excessive weight loss in recent months.cancer.fever.urine and bowl incontinency. needles sensation and numbness in the lower knee. a history of recent trauma to the low back alocate randomly to two groups of 40 (control) and 40 intervention groups.
The 40 patients in intervention group affected by non specific persistent low back pain use a website – specifically created for the project – for a period of 10 week. intervention group subjects educate weekly information about low back pain and aske to perform tailored exercises (strengthening, and stretching and core stability) weekly that will shown on the LBP specific website.
Pain intensity, disability and quality of life Will be measured by the visual analog scale (VAS 0-10 cm) , Roland morris disability questionnaire and (WHOQOL) –BREF questionnaire, respectively, at baseline and at 12 weeks later. The 40 subjects in control group receive all untailored exercises and information after allocating to the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121211736N1
Registration date:2012-12-27, 1391/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-27, 1391/10/07
Registrant information
Name
Fatemeh Taghdir
Name of organization / entity
Sport Medicin Research Center,Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
taghdir_f@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of medical sciences and Health Services
Expected recruitment start date
2012-12-20, 1391/09/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tailored internet–based intervention in patient with non specific persistent low back pain
Public title
Tailored internet–based treatment of low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18 – 65 years old. non-specific low back pain (more than 6 weeks). Internet access and have an e-mail. Able to read and write Farsi.
Exclusion criteria: excessive weight loss in recent months.cancer. malaise.fever.urin and bowl incontinency. needles sensation and numbness in the lower knee. a history of recent trauma to the low back. The decision to perform surgery on the lumbar spine. use a wheelchair. having another disability in addition to back pain.pregnancy .night pain. use of oral corticosteroids.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethinics committee of Tehran University of medical sciences
Street address
Keshavarz Boulvar .ghods street. Education building of Tehran university of medical sciences
City
Tehran
Postal code
Approval date
2012-12-20, 1391/09/30
Ethics committee reference number
92015320746
Health conditions studied
1
Description of health condition studied
Diseases of the musculoskeletal system andconnective tissue
ICD-10 code
M54.5
ICD-10 code description
Low back pain Loin pain Low back strain Lumbago NOS
Primary outcomes
1
Description
Pain intensity
Timepoint
at baseline and at 12 weeks later
Method of measurement
visual analog scale (VAS 0-10 cm)
Secondary outcomes
1
Description
disability
Timepoint
at baseline and at 12 weeks later
Method of measurement
Roland morris disability questionnaire
2
Description
quality of life
Timepoint
at baseline and at 12 weeks later
Method of measurement
(WHOQOL) –BREF questionnaire for quality of life
Intervention groups
1
Description
Intervention group subjects were educated weekly information about low back pain and asked to perform tailored exercises (strengthening, and stretching and core stability) weekly shown on the LBP specific website.
Category
Rehabilitation
2
Description
The subjects in control group received some untailored exercise (strengthening, and stretching and core stability) and information in one time after allocating to study
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Fatemeh Taghdir
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Faculty of Medicine- Tehran University of Medical Sciences- Keshavarz Blvd - Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medicine Research Center, Tehran University of Medical Sciences and Health Services
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
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ramin Kordi
Position
associate professor of Tehran University of Medical Sciences and Health Services
Other areas of specialty/work
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
Email
ramin_kordi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Fatemeh Taghdir
Position
Resident of sports and exercise medicine - Sport Medicine Research Center, Tehran University of Medi
Other areas of specialty/work
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
taghdir_f@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services - Sport Medicine Research Center
Full name of responsible person
Dr. Farough Taee
Position
Medical Student & Research Fellow -Tehran University of Medical Sciences and Health Services
Other areas of specialty/work
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
+98 21 8800 3539
Email
faroughtaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)