A comparison study of the effect of routine physical therapy and routine physical therapy plus an exercise on the Wobble board on the pain, disability index and Paravertebral muscle endurance in women with chronic nonspecific low back pain
Study the effect of routine physical therapy and routine physical therapy plus an exercise on the wobble board on the pain, disability index and paravertebral muscles endurance time in women with chronic nonspecific low back pain
Design
clinical trial with control group , parallel group , randomized , phase 2 on 40 patient , using random number generator from Stat Trek website.
Settings and conduct
40 women with chronic nonspecific low back pain aged between 30-50 year old will inter in this study after checking the inclusion and exclusion criteria by a physician and by the researcher then they will complete a consent form so they will be divided into control or intervention group using randomized number table , patients in the first group will receive 8 session routine physical therapy and patients in the second group will receive 8 session routine physical therapy plus a wobble board exercise. This physical therapy interventions will be done in a private physical therapy clinic in Najafabad of Isfahan.
Pain number, disability percentage and paravertebral muscle endurance time will be recorded before treatment , after treatment and 4 week after treatment.
Participants/Inclusion and exclusion criteria
- 30-50 years old females
- Nonspecific low back pain more than 12 weeks
- No serious pathologies such as vertebral fracture
- No special causes such as spinal canal stenosis or large disc herniation
Intervention groups
Control group will receive routine physical therapy including TENS, hot pack and a series of stretching, strengthening and motor control exercise.
Interventional group will receive routine physical therapy including TENS , hot pack a series of stretching, strengthening and motor control exercise plus an exercise on the wobble board.
A comparison study of the effect of routine physical therapy and routine physical therapy plus an exercise on the Wobble board on the pain, disability index and Paravertebral muscle endurance in women with chronic nonspecific low back pain
Public title
A comparison study of the effect of routine physical therapy and routine physical therapy plus an exercise on the Wobble board on the pain, disability index and Paravertebral muscle endurance in women with chronic nonspecific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30_50 years old females
feeling low back pain more than 12 weeks
Ability of writing and reading
Visual analoge scale : 4 to 8 in last week
Exclusion criteria:
Lumbar spine surgery
Spinal canal stenosis
Severe scoliosis(cob. angle >40)
spondylolisthesis (>grade | )
Ankylosing spondylitis
Large disc herniation ( extrusion and sequestration)
Vertebral fracture
Balance disorders
Radiculopathy
BMI>30
Using analgesics or drugs that disturb balance
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple randomization is used. For generating random sequence, table of random numbers generated by stat Trek website is used, there are 40 numbers in this table which are coding from 01 to 40.
After writing the numbers by the researcher, she will read the randomized number from left to right, so the first 20 codes will be in the control group and the second 20 codes will be in the intervention group.
Based on the time of reference , the participants are coding from 01, 02,...40
till the sample size being completed.
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 Isfahan medical university of science
Street address
No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.
City
Najafabad
Province
Isfehan
Postal code
8518668551
Approval date
2020-03-07, 1398/12/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.464
Health conditions studied
1
Description of health condition studied
Chronic nonspecific low back pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain number
Timepoint
before intervention, after intervention and 4 weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
Disability index percentage
Timepoint
before intervention, after intervention and 4 weeks after intervention
Method of measurement
Oswestry Disability Index
3
Description
paravertebral muscle endurance time
Timepoint
before intervention, after intervention and 4 weeks after intervention
Method of measurement
Sorensen test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 20 patient will be interred in this group and they will receive 8 session routine physical therapy including 20 minuet TENS,10 minute hot pack and a series of exercise including knee to chest and wall stretch as stretching exercises, posterior pelvic tilt and bridge as strengthening exercises and dead-bug and bird-dog as motor control exercises that they will be repeated every day in 3 set of 10 times.
Category
Rehabilitation
2
Description
Intervention group: 20 patient will be interred in this group and they will receive 8 session routine physical therapy including 20 minuet TENS,10 minute hot pack and a series of exercise including knee to chest and wall stretch as stretching exercises, posterior pelvic tilt and bridge as strengthening exercises and dead-bug and bird-dog as motor control exercises that they will be repeated every day in 3 set of 10 times. In addition, in this group exercise on the wobble board which is a sitting balance exercise will be done in the clinic for 3 minutes per session in first week progress to 9 minutes per session in 3rd week .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn Sina physical therapy clinic
Full name of responsible person
Navid Taheri
Street address
No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.
City
Najafabad
Province
Isfehan
Postal code
8518668551
Phone
+98 31 4262 0263
Email
fsayban@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Street address
No.190 , East Golbahar Ave.,South 15 Khordad Ave.,Najafabad.
City
Najafabad
Province
Isfehan
Postal code
8518668551
Phone
+98 31 4262 0263
Email
fsayban@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
فاطمه جراح
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.
City
Najafabad
Province
Isfehan
Postal code
8518668551
Phone
+98 31 4262 0263
Email
fsayban@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid taheri
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.
City
Najafabad
Province
Isfehan
Postal code
8518668551
Phone
009842620263
Email
fsayban@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.190 , East Golbahar Ave., South 15 Khordad Ave., Najafababd.
City
Najafabad
Province
Isfehan
Postal code
8518668551
Phone
+98 31 4262 0263
Email
fsayban@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measures only
When the data will become available and for how long
starting 1 year after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
No limitation
From where data/document is obtainable
fsayban@gmail.com
n_taheri@rehab.mui.ac.ir
What processes are involved for a request to access data/document