Protocol summary

Summary
The objective of this clinical trial is the comparison of the effect of voluntary and automatic training of abdominal muscles on these muscles activity. This experimental study will be done on 60 chronic low back pain patients (male and female) in 18-45 year-old. Transverse abdominis, internal oblique and external oblique thickness will be evaluated by ultrasonography. Then, participants will be randomly assigned into three groups of voluntary muscle contraction (stabilization exercises), automatic contraction of abdominal muscles (doing lower limb diagonal pattern) and control group (no intervention). Six weeks exercise therapy will be done in three sets of ten with two minutes rest between each repetition with the supervision of a physiotherapist in two exercise therapy groups. The control group will be asked to do nothing special other than their routine activity. The thickness of transverse abdominis, internal oblique and external oblique muscles will be evaluated again in all three studied groups at the end of exercise therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015011120639N1
Registration date: 2016-03-10, 1394/12/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-10, 1394/12/20
Registrant information
Name
Mehdi Kianiasl
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
kaymehdi68@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of automatic and voluntary training on lateral abdominal muscles thickness in chronic non-specific low back pain patients.
Public title
Comparing two voluntary and involuntary training of abdominal muscles on the size of them in chronic low back pain patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with nonspecific low back pain, average age of 18-45 years, history of low back pain lasting 3 mounts during one year ago. Exclusion criteria: history of diabetes, muscloskeletal disorders, systemic diseases, spondylolysis and spondylolisthesis, history of previous surgery in the spinal region, history of lumbar trauma during previous year of the study, disk herniation, nerve root comparison, polyneuropathies, carsinoma, malignancy of the spinal region, balance disorders, pregnancy, history of back training during 3 months before the study, drugs using with side effect on the postural control system.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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 committee of Semnan University of Medical Sciences
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, the 5th kilometers of Damghan road
City
Semnan
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
93/584688

Health conditions studied

1

Description of health condition studied
Chronic non- specific low back pain
ICD-10 code
M99.9
ICD-10 code description
Biomechanical Lesion, Unspecified

Primary outcomes

1

Description
Transvers abdominis, internal oblique and external oblique muscle thikcness
Timepoint
Before and 6 weeks after intervention
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Pain and disability
Timepoint
Begening of study, after 6 weeks intervention
Method of measurement
Roland-Morris disability questionnair, Visual analogue scale

Intervention groups

1

Description
Doing 6 weeks of voluntary contraction of abdominal muscles, three times a week
Category
Rehabilitation

2

Description
Doing 6 weeks of automatic training of abdominal muscles, three sessions a week
Category
Rehabilitation

3

Description
No intervention during 6 weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidipour (Research deputy of Semnan University of Medical Sciences)
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Amir Kabir Bridge, Basij Blvd.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Dr. Rozita Hedayati
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, The 5TH kilometers of Damghan road.
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
rosehed@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
Dr. Rozita Hedayati
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, The 5th kilometers of Damghan road.
City
Semnan
Postal code
Phone
+98 233333895
Fax
Email
rosehed@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rozita Hedayati
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, The 5th kilometers of Damghan road
City
Semnan
Postal code
Phone
Fax
Email
rosehed@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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