The purpose of the present study is improvement of chronic non specific low back pain patients with trunk balances exercises or whole body vibration. Also we want to compare the effect of these interventions. Patients between 20-50 with diagnosis of chronic non-specific low back pain participate in this study. The patients are randomized into two groups: modality and trunk balance exercises are performed for the first group, while the other group undergo modality with whole body vibration( WBV). Before and after treatment, pain( with Visual Analog Scale( VAS) ,functional disability( with Rolland Morris disability questionnaire), and static and dynamic balance ( with specific functional tests) are measured. More over, thickness and cross sectional area( CSA) of transvers abdominus (TrA), internal oblique, external oblique and multifidus muscles are measured with rehabilitative ultrasonography. Treatments consist of 18 sessions(3 sessions per week). flow up is done one month after treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072229029N1
Registration date:2016-09-06, 1395/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-09-06, 1395/06/16
Registrant information
Name
Farahnaz Emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
emamif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of trunk balance exercises and whole body vibration on the postural control of the patients with chronic non-specific low back pain.
Public title
The effect of balance exercises and whole body vibration on low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria ; Pain intensity between 3-7( according to VAS);Functional disability level higher than 8( according to Roland Morris Disability index)؛
Exclusion criteria;Untreated visual and auditory deficit;History of convulsion and epilepsy; Herniation ( abdominal and disc); acute infection;Bone FX and tendon sprain in the previous 6 weeks;Migraine;Internal fixation in skeletal system; Kidney and urinary stones;Sever cardiovascular disease;Sever osteoporosis; medication that affected on postural control;Vestibular disorders;Major spinal surgery ( presence of limitation of motion ); Recently lower extremities and joint disease during three last month;Spinal deformity;Vertebral tumor and metastasis;Diabetes;Previous physiotherapy treatment ( in the last month);Pregnancy during last year;Limb length discrepancy more than 1 cm.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shiraz University of Medical Sciences
Street address
Zand str, next to red crescent organization
City
Shiraz
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SUMS.REC.1395.72
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
Dynamic balance
Timepoint
baseline, end of study
Method of measurement
Y balance test
2
Description
Static balance
Timepoint
baseline, end of study
Method of measurement
One leg stance test
Secondary outcomes
1
Description
Differences of cross sectional area of TrA, Internal oblique, External obliqe and multifidus muscles billaterally
Timepoint
baseline, end of study
Method of measurement
Ultrasonography device
2
Description
Pain
Timepoint
baseline, end of study, one month after the end of study
Method of measurement
Visual analog scale
3
Description
Disability
Timepoint
baseline, end of study, one month after the end of study
Method of measurement
Rollamd Morris Questionare
4
Description
differences of cross sectional area of TrA, Internal oblique, External obliqe and multifidus billaterally
Timepoint
baseline, end of study
Method of measurement
Ultrasonography device
Intervention groups
1
Description
In balance training group intervention consists of 18 sessions,3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 microsec, amplitude as tolerated, hot pack,US = 1 MHz,intensity 1.5 w/cm2) are used. After that, patients execute trunk balance exercises in 5 levels. The levels of exercises are simple to difficult,and if his/her pain increases, the patient remains at the same level of exercises. The total duration of treatment is 6 weeks ,3 times per week .
Category
Treatment - Other
2
Description
For the whole body vibration group intervention consists of 18 sessions, 3 times and 6 weeks.Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 microsec, amplitude as tolerated, hot pack,US = 1 MHz,intensity 1.5 w/cm2) are used. After that , whole body vibration device (sinusoidal mode, frequency= 20 Hz,amplitude= 4mm, a= 5.8 g) is used for them. The patients stands with 20 flexion of knee joints on plate form. 5 boot uses in each session with 1 minute rest between them. Duration of each boot in first 2 week is 30 seconds, in second 2 week 45 seconds and in the last 2 week is 1 minute. The total duration of intervention is the same as other group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of school of rehabilitation
Full name of responsible person
Farahnaz Emami
Street address
Abivardi 1 str, Chamran Blvd.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Zand str., next to Red crescent
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farahnaz Emami
Position
PhD candidate of physiotherapy
Other areas of specialty/work
Street address
Abivardi 1 str., Chamran Blvd.
City
Shiraz
Postal code
Phone
+98 71362715512
Fax
Email
emamif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohsen Razeghi
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Abivardi 1 str.و Chamran Blvd.
City
Shiraz
Postal code
Phone
+98 71362715512
Fax
Email
razeghm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farahnaz Emami
Position
PhD candidate of physiotherapy
Other areas of specialty/work
Street address
Abivardi 1 str., Chamran Blvd.
City
Shiraz
Postal code
Phone
+98 71362715512
Fax
Email
emamif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)