Comparison of the effect of exercise on stable surface versus unstable surface on cross section area of lumbar stabilizer muscle, pain, disability index, static and dynamic balance in patients with chronic low back pain
Comparison of the effect of exercise on stable surface versus unstable surface on cross section area of lumbar stabilizer muscle, pain, disability index, static and dynamic balance in patients with chronic low back pain(LBP)
Design
two arm parallel group randomized trial. participants and outcome assessor will be blind. 40 participants will be randomly allocated to the 2 groups via permuted block randomization with block of size 2.
Settings and conduct
This study will be done in Rehabilitation Sciences Research Center and Clinic, Shiraz University of Medical Sciences, Shiraz, Iran on 40 individual with chronic LBP. The individuals will be assessed by a blind assessor and allocated randomly into the 2 groups: treatment on stable and unstable surface.They will receive18 sessions of treatment during 6 weeks and will be followed up after 1 month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mechanical LBP without radicular symptoms such as radiating pain below the knee, loss of sensation, or loss of reflex; pain intensity of 3–6 in the VAS; 18-40 years old. Non-inclusion criteria: Pregnancy; Spinal fractures; Herniated discs; Acute LBP; spondylolisthesis and spondylolysis; lower limb length discrepancy; previous surgery on vertebral column; specific diseases causing back pain such as malignancy, rheumatologic conditions; severe osteoporosis; stabilization exercise performance within last 6 weeks; Athletes; Neurological diseases; BMI above 26; Disability more than 60% in the oswestry Disability index; Uncontrolled disorders of the liver, kidney and thyroid
Intervention groups
Intervention group 1: common physical therapy treatment group and exercise on unstable surface. Intervention group 2: common physical therapy treatment group and exercise on stable surface.
Main outcome variables
Thickness of lumbar stabilizer muscle,balance, pain, disability index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190527043730N1
Registration date:2019-07-16, 1398/04/25
Registration timing:registered_while_recruiting
Last update:2019-07-16, 1398/04/25
Update count:0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
mozhgan emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3743 6244
Email address
emami.mozhgan73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of exercise on stable surface versus unstable surface on cross section area of lumbar stabilizer muscle, pain, disability index, static and dynamic balance in patients with chronic low back pain
Public title
Effect of lumbar stabilization exercise performed on stable versus unstable surfaces in chronic low back pain patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 40 years
mechanical low back pain(LBP) but no radicular symptoms such as radiating pain below the knee, loss of sensation, or loss of reflex
pain intensity of 3–6 in the Visual Analogue Scale (VAS)
Exclusion criteria:
Pregnancy
Spinal fractures
Herniated discs
Acute low back pain
spondylolisthesis and spondylolysis
lower limb length discrepancy
previous surgery on vertebral column
specific diseases causing back pain such as malignancy, rheumatologic conditions
severe osteoporosis
recent stabilization exercise performance (within last 6 weeks)
Athletes
Neurological diseases
body mass index(BMI) above 26
Disability more than 60% in the oswestry Disability index
Uncontrolled disorders of the liver, kidney and thyroid
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals with block randomization and sealed opaque envelopes concealment take place in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study evaluations and intervention are performed by two different physiotherapists.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Shiraz School of Rehabilitation sciences
Street address
School of Rehabilitation Sciences, Abiverdi 1 st., Chamran Blvd., Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.SUMS.REHAB.REC.1397.025
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Thickness of lumbar stabilizer muscle
Timepoint
Pre and post intervention (after 6 weeks)
Method of measurement
ultrasound device
Secondary outcomes
1
Description
pain
Timepoint
pre and post intervention (after 6 weeks) and fallow up (after 10 weeks)
Method of measurement
visual analogue scale
2
Description
static balance
Timepoint
pre and post intervention (after 6 weeks)
Method of measurement
open and close eye single leg stance
3
Description
dynamic balance
Timepoint
pre and post intervention (after 6 weeks)
Method of measurement
modified star excursion balance test
4
Description
disability
Timepoint
pre and post intervention (after 6 weeks) and fallow up (after 10 weeks)
Method of measurement
oswestry disability index
Intervention groups
1
Description
Intervention group 1: This group will receive the common physical therapy treatment and exercise on unstable surface for 18 session during a period of 6 weeks. lumbar stabilization exercise program progressively increase during the 6-week exercise program. The subjects will ask to perform three sets of 10 repetitions during the first and second week, progress to three sets of 15 repetitions during each session in the third and fourth weeks, and three sets of 20 repetitions during the fifth and sixth weeks.
Category
Treatment - Devices
2
Description
Intervention group 2: This group will receive the common physical therapy treatment and exercise on stable surface for 18 session during a period of 6 weeks. lumbar stabilization exercise program progressively increase during the 6-week exercise program. The subjects will ask to perform three sets of 10 repetitions during the first and second week, progress to three sets of 15 repetitions during each session in the third and fourth weeks, and three sets of 20 repetitions during the fifth and sixth weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinics in Shiraz city
Full name of responsible person
Shohreh Taghizadeh
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Boulvard
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 1626 1081
Email
taghizsh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ghasemi Unes
Street address
Floor 7, Center bilding of Shiraz Univercity of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
71345-1974
Phone
+98 71 7282 3235
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?