Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT201502064231N3 |
Date of registration:
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2015-02-21 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The effect of individualized core stability exercises on management of subacute and chronic low back pain with radiculopathy.
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Scientific title:
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The effect of individualized core stability exercises on management of subacute and chronic low back pain with radiculopathy. |
Date of first enrolment:
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2015-04-04 |
Target sample size:
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20 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/4493 |
Study type:
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interventional |
Study design:
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Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr. Ramin Kordi
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Address:
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No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
Tehran
Iran (Islamic Republic of) |
Telephone:
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+98 21 8863 0227 |
Email:
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ramin_kordi@tums.ac.ir |
Affiliation:
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Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services |
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Name:
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Dr. Pardis Noormohammadpour
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Address:
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No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran
Tehran
Iran (Islamic Republic of) |
Telephone:
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+98 21 8863 0227 |
Email:
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normohamadpour@tums.ac.ir |
Affiliation:
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Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services |
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Key inclusion & exclusion criteria
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Inclusion 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.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
65 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases of the musculoskeletal system and connective tissue. Lumbago with sciatica
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Lumbago with sciatica
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Intervention(s)
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Rehabilitation
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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 Seco
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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.
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Primary Outcome(s)
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Low back pain and radicular Pain. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: VAS.
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Secondary Outcome(s)
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Fear avoidance beliefs. Timepoint: Before the intervention, 8 weeks after. Method of measurement: Iranian version of fear avoidance beliefs questionnaire.
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Quality of life. Timepoint: Before the intervention, 8 weeks after. Method of measurement: Iranian version of WHOQOL: BREF questionnaire.
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Disability. Timepoint: Before the intervention, 8 weeks after. Method of measurement: Iranian version of Roland and Morris Disability Questionnaire.
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Lateral Abdominal muscles thicknesses(transverse abdominis, internal oblique, and external oblique thickness). Timepoint: Before the intervention, 4 week after & 8 week after. Method of measurement: ultrasound.
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Paravertebral muscles thicknesses. Timepoint: Before the intervention, 4 week after & 8 week after. Method of measurement: ultrasound.
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Source(s) of Monetary Support
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Tehran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Tehran University of Medical Sciences and Health Services - Ethics committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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