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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18 June 2018 |
Main ID: |
IRCT20090203001637N9 |
Date of registration:
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2018-05-20 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study and comparison of two therapeutic exercise approach with and without manual therapy on improving pain, range of motion , functional disability and balance in patients with low back pain.
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Scientific title:
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Evaluation of Combination therapy "SNAG - Lumbar Stabilization Exercise" treatment versus Stabilizing Exercises on improving pain, range of motion , functional disability and postural stability in patients with chronic non-specific low back pain. |
Date of first enrolment:
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2017-09-23 |
Target sample size:
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30 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/1101 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method is performed by simple randomization with random numbers, Blinding description: Participants were aware of two methods of interventions, but they were blind to the type of treatment intervention used for them .
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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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Sedighe Kahrizi
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Address:
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Tarbiat Modares University, Jalal e Al Ahmad Avenue , Nasr Bridge, Tehran
1411713116
Tehran
Iran (Islamic Republic of) |
Telephone:
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+98 21 8288 4511 |
Email:
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kahrizis@modares.ac.ir |
Affiliation:
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Tarbiat Modares University |
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Name:
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Mehrnoosh Danaeifar
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Address:
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Tarbiat modares university, Tehran, JALAL E al ahmad Avenue , Nasr bridge
1411713116
Tehran
Iran (Islamic Republic of) |
Telephone:
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+98 21 8288 4511 |
Email:
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Mehrnooshdanaeifar@modares.ac.ir |
Affiliation:
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Tarbiat Modares University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Having age between 25 to 50. Having at least high school diploma education. Having chronic non-specific chronic back pain for more than three months without neurological deficit. Having body mass index between 20 to 25 (kg/m2). Having localized pain at the waist level between 3 to 6 as VAS (Visual Analog Scale 0-10 centimeter) , during lumbar extension in sitting position on test day. Having positive PILL Response scale(pain free ,immediate ,long lasting ) as Mulligan concept. having functional disability between 20-40 % as Oswestry questionnaire.
Exclusion criteria: Having history of trauma,surgery in back or stomach ,fracture in vertebral spine . having any sign and symptom of pressure on cauda equinq nerve. Presence of pregnancy, infection, tumor, inflammation and swelling, osteoporosis, rheumatism, systemic and neuromuscular diseases. Having any deformity in vertebral spine. Having a history of physical therapy for back pain in the last 3 months. Use of analgesics. Presence of disk protrusions (based on MRI) and diagnosis of orthopedic surgeon. Presence of referral pain from lumbar to under the legs or the knees. Losing any of inclusion criteria.
Age minimum:
25 years
Age maximum:
50 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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patients with nonspecific chronic low back pain. Low back pain
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Intervention(s)
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Intervention 1: Combination of Mulligan Mobilization with Stabilization Exercise. Intervention 2: Intervention group:Stabilization Exercise protocol.
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Primary Outcome(s)
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Balance. Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session)last session(seventh session). Method of measurement: Force plate system.
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Secondary Outcome(s)
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Functional disability. Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session). Method of measurement: Oswestry Questionaire.
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Pain in lumbar spine. Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session). Method of measurement: Visual analog scale (VAS).
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Range of motion of lumbar vertebral. Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session). Method of measurement: Modified modified Schober method.
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Source(s) of Monetary Support
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Research deputy of Tarbiat Modares University
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics committee of Tarbiat Modares University
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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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