The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance (lumbosacral)

Medipol Health Group

Status: Active, not recruiting

Conditions: Orthosis; Low Back Pain, Postural

Treatments: Other: First Intervention; Other: Second Intervention; Other: Third Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06289088

E-10840098-772.02-4659

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

First Intervention

Experimental group

Description:

The application will be done sequentially: without orthosis, with adaptation and with orthosis.

Treatment:

Other: First Intervention

Second Intervention

Experimental group

Description:

The application will be done sequentially: with adaptation, with orthosis and without orthosis

Treatment:

Other: Second Intervention

Third Intervention

Experimental group

Description:

The application will be done sequentially: with orthosis, without orthosis, and with adaptation

Treatment:

Other: Third Intervention