Effect of Extensible and non-Extensible Lumbosacral Orthoses on the Flexion Relaxation Phenomenon in Patients with Chronic non-Specific Low Back Pain

Effect of Extensible and non-Extensible Lumbosacral Orthoses on the pain, disability, and Flexion Relaxation Phenomenon in Patients with Chronic non-Specific Low Back Pain

The present study is a parallel-group, randomized clinical trial with the outcome assessor blinded. Patients with Chronic non-specific LBP will be randomly assigned to extensible or non-extensible lumbosacral orthosis groups.

All the assessments, interventions, and data collection steps will be carried out at the School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences. The outcome assessor and statistician will be blinded.

Inclusion criteria: 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 Exclusion criteria: having non-musculoskeletal LBP 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

One group will be received an extensible lumbosacral orthosis and another group will be received a non-extensible lumbosacral orthosis. All patients will be asked to wear the LSO all day long for 4 weeks, except during rest and sleeping hours.

pain intensity on VAS Oswestry Disability Index

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.

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.

There is no plan for IPD publication.

Our research findings will be shared with all researchers, and practitioners. We will publish our research findings in scientific journals.

All documents can be shared 1 year after article publication

Researchers and health practitioners

Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article

Fatemeh Azadinia

Send email to corresponding author.