The main objective of this study is investigation the effect of core stability exercises for management of radicular/discogenic low back pain.
This is a quasi-experimental study. Twenty patients (between 18 to 65 years old) with a radicular low back pain for more than six weeks with a related annular tear or protrusion in the MRI without absolute or relative indications for surgery, will be recruited in the study. After related physical examinations, core stability exercises (may be modified based on patients’ symptoms) will be prescribed for each patient.
Iranian version of Roland Morris Disability questionnaire, WHOQOL: BREF questionnaire, Fear-Avoidance Beliefs questionnaire, and VAS will be completed by the participants at the beginning and eight weeks after the study. In addition, the thickness of lateral abdominal muscles and cross sectional area of paravertebral muscles will be measured via ultrasound at the beginning, four weeks and eight weeks after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502064231N3
Registration date:2015-02-21, 1393/12/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-21, 1393/12/02
Registrant information
Name
Pardis Noormohamadpour
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
normohamadpour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individualized core stability exercises on management of subacute and chronic low back pain with radiculopathy.
Public title
The effect of individualized core stability exercises on management of subacute and chronic low back pain with radiculopathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient should be between 18 to 65 years old; Having a radicular low back pain for more than six weeks with a related annular tear or protrusion in the MRI; Having a continus or intermittent radicular pain or parestesia in lower limbs which is related to the affected disc levels.
Exclusion criteria: Having absolute or relative indications for surgery such as cauda equina syndrome, paraparesis/paraplegia, and severe paresis or pain which has not improved over conservative treatments; Not complying with the rehabilitation program and continuing the study; Getting pregnant during the study; History of systemic disease affecting the musculoskeletal functions, musculoskeletal deformity or abnormality with possible influence on the thickness of lateral abdominal muscles or paravertebral muscles (such as muscular dystrophy, abdominal hernia, and scleroderma); History of lumber surgery; History of lumber malignancy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services - Ethics committee
Street address
Faculty of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
93-03-53-27292
Health conditions studied
1
Description of health condition studied
Diseases of the musculoskeletal system and connective tissue
ICD-10 code
M54.4
ICD-10 code description
Lumbago with sciatica
Primary outcomes
1
Description
Low back pain and radicular Pain
Timepoint
Before the intervention, 8 weeks after intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Disability
Timepoint
Before the intervention, 8 weeks after
Method of measurement
Iranian version of Roland and Morris Disability Questionnaire
2
Description
quality of life
Timepoint
Before the intervention, 8 weeks after
Method of measurement
Iranian version of WHOQOL: BREF questionnaire
3
Description
fear avoidance beliefs
Timepoint
Before the intervention, 8 weeks after
Method of measurement
Iranian version of fear avoidance beliefs questionnaire
Before the intervention, 4 week after & 8 week after
Method of measurement
ultrasound
5
Description
Paravertebral muscles thicknesses
Timepoint
Before the intervention, 4 week after & 8 week after
Method of measurement
ultrasound
Intervention groups
1
Description
Eight weeks of core stability exercises (modified based on patient's symptoms): 1) Lie on back, Tighten abdominal muscles , press back down into floor - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 2) Begin on knees and hands, Tighten abdominal muscles- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 3) Walk with tightening abdominal muscles-30 minutes per day 4) Do your daily works with tightening abdominal muscles 5) Lie on back, Lift your buttocks off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 6) Begin on knees and hands, Extend your leg while lifting the opposite arm- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 7) Lie on your side, Raise your thighs and hips off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 8) Lie on back, Move your elbow to opposite knee. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 9) Lie on back, Raise your leg and ipsilateral arm off floor- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 10) Lie face down, raising your arms and legs off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 11) Lie on back, bent your legs, Rotate your legs from side to side. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 12) Begin standing, Raise one knee up. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 13) Begin standing, do lunge. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 14) Begin standing, do lunge, Raise one knee up. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds In addition, there are similar exercises on the sport ball - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ramin Kordi
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Faculty of Medicine- Tehran University of Medical Sciences- Keshavarz Blvd - Tehran
City
Tehran
Grant name
93-03-53-27292
Grant code / Reference number
93-03-53-27292
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ramin Kordi
Position
Associate Professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Postal code
Phone
+98 21 8863 0227
Fax
Email
ramin_kordi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Pardis Noormohammadpour
Position
Assistant Professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Postal code
Phone
+98 21 8863 0227
Fax
Email
normohamadpour@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Pardis Noormohammadpour
Position
Assistant Professor of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
City
Tehran
Postal code
Phone
+98 21 8863 0227
Fax
Email
normohamadpour@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)