This study is intended to check the effect of group training and back book compared with routine physiotherapy in chronic low back pain. Patients who are referred to physiotherapy clinics of Semnan university of medical sciences. It is done in a single blind randomized clinical trial method on 70 patients (35 in each group) all the patients are aged between 18- 65 and have suffered pain for at least 3 months. Patients with pain for less than 3 month and patients with medical diseases will exclude.
They are placed in 2 groups at random. Data including age, sex, education, occupation, body mass index, history of previous illnesses and treatments is recorded for all patients. The patients in control group will receive routine physiotherapy treatments including Tens, Ultrasound, Hot pack, Laser 3 times a week for 6 weeks. The cases will receive routine physiotherapy treatments and group exercises (1 hour a week) for 6 weeks and a regular walking program (3 times a week ).Finally they will be followed up twice. Once after each month following the completion of the treatment. Score of pain (VAS), functional disability (Oswestry questionaire) , respiratory status (spirometry ) and Single limb stance for lumbar position will be evaluated .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041921847N1
Registration date:2015-08-31, 1394/06/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-31, 1394/06/09
Registrant information
Name
Armin Sahba
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3335 4180
Email address
armin@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group exercise therapy with the instructional pack versus usual physiotherapy programme in improvement of patients with low back pain
Public title
Effectiveness of group exercise therapy with the instructional pack in improvement of patients with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mechanical chronic low back pain above 3 months؛ Male and female age between 18 to 65؛ Patients without spinsl surgery during last year
Exclusion criteria:
Duration of low back pain under 3 months؛ History of inflammatory systemic diseases such az Rheumatoid arthritis؛ History of severe spinal canal stenosis such as Spondylolisthesis and Fibromyalgia؛ History of cancers or recent radiotherapy and chemotherapy؛ Pregnancy؛ Cardiovascular disease؛ Severe psichiatric diseases؛ Surgery of spinal cord؛ Lumbar physiotherapy during recent 6 months؛ Illiterate patients
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization table of random numbers
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
93/584659
Health conditions studied
1
Description of health condition studied
chronic low back pain
ICD-10 code
m54.5
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Befor treatment and after first and second month of treatment
Method of measurement
Visual analog score
2
Description
Functional disability
Timepoint
Befor treatment and after first and second month of treatment
Method of measurement
Oswestry Disability Index Questionnaire
3
Description
respiratory function
Timepoint
Befor treatment and after first and second month of treatment
Method of measurement
spirometry
Secondary outcomes
empty
Intervention groups
1
Description
"The intervention group": The intervention group members will receive Usual physiotherapy treatment plus group exercise therapy classes which are held by the physiotherapist twice a week. the walking program commences with 10 minutes walking 4 days a week and will gradually increase up to 30 minutes 5 days a week. The duration of the treatment will be 6 weeks.
Category
Rehabilitation
2
Description
" Control group: the group which receive usual physiotherapy treatment includes TENS, Ultrasound, Hot pack, Laser and exercise for 6 weeks"
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Aveccina Physiotherapy clinic of Semnan University of Medical Sciences
Full name of responsible person
Armin Sahba
Street address
Aveccina Physiotherapy clinic, Saadi Square, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Semnan University of Medical Sciences
Full name of responsible person
Vice chancellor for research,Semnan University of Medical Sciences
Street address
Vice chancellor for research Semnan University of Medical Sciences, Basij blvd, Semnan, Iran
City
Semnan
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,Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Armin Sahba
Position
Physiotherapist
Other areas of specialty/work
Street address
Aveccina Physiotherapy clinic, Saadi Square, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3332 2332
Fax
+98 23 3332 2332
Email
arminsahba@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amoozadeh Khalili
Position
Physiotherapist
Other areas of specialty/work
Street address
Aveccina Physiotherapy clinic, Saadi Square, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3332 2332
Fax
+98 23 3332 2332
Email
moh35ir@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Armin Sahba
Position
Physiotherapist
Other areas of specialty/work
Street address
Aveccina Physiotherapy clinic, Saadi Square, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3332 2332
Fax
+98 23 3332 2332
Email
arminsahba@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)