Clinical trial NCT06289088: The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance
Official title: The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance in Individuals With Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthosis
Low Back Pain, Postural
Keywords: Low back pain
lumbosacral orthosis
orthosis adjustment
postural control
plantar pressure
balance
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single group, crossover study
Primary purpose: OTHER

Brief summary: The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain.

Detailed description: The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. Thirty male and female volunteers between the ages of 18-65 who came to Istanbul Medipol University Prosthesis Orthotics Center and experienced low back pain were included in the study.

The study will be designed as Crossover. The study consists of three methods and a single group, which are orthosis-free, worn by a person with low back pain, and adapted by a prosthetist orthotist. Following both orthosis insertion methods, pain severity will be measured with Visual Analogue Scale (VAS) and comfort level was measured with Orthosis Comfort Score. They will be asked to wait for 30 minutes with orthosis, and then the pain severity and comfort level were measured again. Y Balance Test (YBT) and Functional Reach Test (FRT) will be used for dynamic balance. Plantar pressure and static balance will be analyzed with pedobarography device. Static Pressure and stabilometric data will be found.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65,
* One or more recurrent low back pain during the last 12 months,-At least 6 points on the Oswestry Disability Index,
* Negative straight leg raising test result,
* Not having any lower extremity injuries in the last 6 months,
* No history of recent trauma or infection

Exclusion Criteria:

* Neurological symptoms due to nerve root compression
* One-sided leg pain more severe than lower back pain, pain in feet and toes shooting pain, numbness in the same area, paresthesia,
* Disease that causes neurological sequelae (stroke, traumatic brain injury, Parkinson's, Those who have had it (such as multiple sclerosis),
* Presence of malignancy,

Primary outcomes:
measure: Visual Analog scale
timeFrame: 5 minutes
measure: Orthosis comfort score
timeFrame: 10 minutes
measure: Functional Reach Test (FRT)
timeFrame: 5 minutes
measure: Pedobarographic evaluation
timeFrame: 5 minutes
measure: Y balance test
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: MERVE YILMAZ MENEK, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azadinia F, Ebrahimi-Takamjani I, Kamyab M, Asgari M, Parnianpour M. Immediate Effects of Lumbosacral Orthosis on Postural Stability in Patients with Low Back Pain: A Preliminary Study. Arch Bone Jt Surg. 2019 Jul;7(4):360-366.