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IRCT20200315046784N2 IRCT 2022-06-17 Iran University of Medical Sciences Effect of lumbosacral orthosis on non-specific chronic low back pain Effect of Extensible and non-Extensible Lumbosacral Orthoses on the Flexion Relaxation Phenomenon in Patients with Chronic non-Specific Low Back Pain 2022-06-19 anticipated 40 Complete https://irct.ir/trial/63930 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 32, however, to take account of potential withdrawals, 40 patients (n=20 per group) will be recruited for the study. First, create and seal 20 treatment A envelopes and 20 treatment B envelopes. To create a block of 4, we will select 2 treatment A envelopes and 2 treatment B envelopes. We will shuffle these 4 envelopes thoroughly, and place this block of 4 in a separate pile. Then, we will prepare additional blocks of 4 until all 20 treatment A and B envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 10 individual piles of shuffled blocks of 4, for example AABB, BBAA, ABBA, BAAB, ABAB, BABA, Blinding description: The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis , and the patients will remove their orthosis before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician. N/A non-specific chronic low back pain. Intervention 1: Intervention group: Group A will be received an extensible lumbosacral orthosis. The patients will be asked to wear the orthosis all day long for 4 weeks. Intervention 2: Intervention group: Group B will be received a non-extensible lumbosacral orthosis. The patients will be asked to wear the orthosis all day long for 4 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan for IPD publication.
public Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences scientific Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) age 18 to 65 yrs history of LBP for at least 12 weeks pain intensity of at least 3 on VAS a score of at least 12% on the ODI Standing and walking without assistance not receiving orthosis, kinesio-tape and or physical therapy for the last 3 months 18 years 65 years Both neurological symptoms due to nerve root compression severe spinal deformities history of spinal or abdominal surgery systemic diseases neuromuscular diseases BMI of more than 30 Antidepressive, Anxiolytic, Anticonvulsant drugs M54.5 Low back pain Treatment - Devices Treatment - Devices Intervention group: Group A will be received an extensible lumbosacral orthosis. The patients will be asked to wear the orthosis all day long for 4 weeks.. Intervention group: Group B will be received a non-extensible lumbosacral orthosis. The patients will be asked to wear the orthosis all day long for 4 weeks. Disability score on Oswestry Disability Index. Timepoint: before and after 4 weeks intervention. Method of measurement: Oswestry Disability Index. Pain intensity. Timepoint: before and after 4 weeks intervention. Method of measurement: Visual analogue scale. Fear of movement (kinesiophobia). Timepoint: before and after 4 weeks intervention. Method of measurement: Tampa Scale of Kinesiophobia. Back muscle endurance. Timepoint: before and after 4 weeks intervention. Method of measurement: Biering-Sørensen Test. Flexion relaxation ratio. Timepoint: before and after 4 weeks intervention. Method of measurement: electromyography. Iran University of Medical Sciences Approved 2021-06-29 the ethics committee of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)