Comparison of stabilization exercise and general exercise on enhancing back stability in non-specific chronic low back pain patients using a biomechanical model(EMG-based)
Objectives: There is a controversy about core stability exercise(CSE) in the literature. Some believe that this type of exercise has no special effect on LBP and only has some useful physiologic effects like other general exercises. Researches which have assessed this exercise had pain, disability, health related quality of life and ... as outcome measures and no study was found related to back stability. As the aim of CSE is to enhance back stability by improving local muscle contraction, assessing back stability in CSE is important. We decided to use a EMG-based biomechanical model to assess back stability.
Design: Randomized, Phase 2 clinical trial
Setting and conduct: Low back pain patient referred to physiotherapy department of Rasool hospital, Tehran, Iran were conducted in this study
Participants including major eligibility criteria: Inclusion Criteria: Non-specific low back pain and pain VAS of 3-6 and exclusion criteria :any pathology or anomaly in lower extremity or spine
Intervention: Subjects are randomly allocated in core stability and general exercise groups. Both exercises groups protocols are based on the study conducted by Koumantakis et al in 2005 (Trunk Muscle Stabilization Training Plus General Exercise Versus General Exercise Only). Interventions and training will continue for 6 weeks (tree session each week, total 16 sessions).
Main outcome measures: By taking EMG from trunk muscles(Rectus, external and internal oblique, longisimus and iliocostalis) and using biomechanical equations we can estimate muscles force and so muscles stiffness. Stability index which is obtained in this way will be our main outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111098035N1
Registration date:2013-01-21, 1391/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-21, 1391/11/02
Registrant information
Name
MohammadBagher Shamsi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3838 4185
Email address
mshamsi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of medical sciences
Expected recruitment start date
2012-07-14, 1391/04/24
Expected recruitment end date
2013-02-12, 1391/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of stabilization exercise and general exercise on enhancing back stability in non-specific chronic low back pain patients using a biomechanical model(EMG-based)
Public title
Comparison of two types of exercise on enhancing back stability in non-specific chronic low back pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Non-specific LBP for more than 3 months; age 18-60 years; pain 3-6 in VAS scale.
Exclusion Criteria: Any pathology or anomaly in lower extremity or spine (like malignancy; inflammatory diseases; sever osteoporosis and bone and joint diseases); history of disc herniation or surgery in the spine.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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 commitee of Tehran University of medical Sciences
Street address
Keshavarz Bulevard, corner of Ghods Street
City
Tehran
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
130/670/د/1
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Lumbar Stability index using a biomechanical model
Timepoint
Before and after the intervention
Method of measurement
Electromyografic signals of 5 abdominal and back muscles are taken and in a model they are converted to stability index.
Secondary outcomes
1
Description
Oswestry disability index
Timepoint
Before and after intervention
Method of measurement
Questionnaire
2
Description
Core stability
Timepoint
Before and after intervention
Method of measurement
With core endurance tests (trunk flexion and extension, and bilateral side bridge) and dynamic functional tests (Dip, single leg squat and runner pose)
3
Description
Abdominal muscle thickness (rectus, obliques and transverse)
Timepoint
Before and after intervention
Method of measurement
With ultrasonographic imaging
Intervention groups
1
Description
16 session of core stabilization exercise (3 each week) based on study of Koumantakis
Category
Rehabilitation
2
Description
16 session of general exercise (3 each week) based on study of Koumantakis
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Department, Rasool Akram Hospital
Full name of responsible person
MohammadBagher Shamsi
Street address
Niayesh Street, Satarkhan Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of medical sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
6th floor, University central office, corner of Ghods street, Keshavarz bulevard
City
Tehran
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, Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
MohammadBagher Shamsi
Position
MsC, PhD candidate
Other areas of specialty/work
Street address
School of Rehabilitation, Shahnazari street, Mُohseni Square,
City
Tehran
Postal code
Phone
+98 21 4408 7889
Fax
Email
mshamsi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
PhD candidate, MsC
Other areas of specialty/work
Street address
School of Rehabilitation, Shahnazari street, Mُohseni Square,
City
Tehran
Postal code
Phone
00
Fax
Email
mshamsi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)