The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients

Study Overview
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Brief Summary
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The dissertation will focus on the possibilities of using pressure sensors during physiotherapy care. A single-blind randomized study will be conducted on a sample of at least 40 probands of working age with chronic LBP in the age range of 30-65 years. The following exclusive criteria are established: signs of serious spinal pathology (red flags), severe musculoskeletal trauma in the last year, vestibular, visual or neurological dysfunction affecting stability, ongoing pregnancy or breastfeeding, acute respiratory disease, cognitive dysfunction leading to misunderstanding of instructions and severe cardiac or internal disease. Inclusive and exclusive criteria will be evaluated by a rehabilitation doctor during a comprehensive examination before the start of therapy. All probands will undergo six-week outpatient therapy once a week. The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week. The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device. Before the start and at the end of the six-week therapy, all probands will be blindly evaluated for the quality of activation and use of intra-abdominal pressure with the DNS Brace device. At the same time, the Oswestry Disability Index questionnaire will be used to subjectively evaluate the probands before and after a series of therapies. The aim of the study is to demonstrate the possibility of using pressure sensors to improve the effect of physiotherapy.

Official Title
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The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Device: OhmTrak device.
* Other: Outpatient Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with chronic Low Back Pain age range of 30-65 years. Exclusion Criteria: signs of serious spinal pathology (red flags) severe musculoskeletal trauma in the last year vestibular, visual or neurological dysfunction affecting stability ongoing pregnancy or breastfeeding acute respiratory disease cognitive dysfunction leading to misunderstanding of instructions severe cardiac or internal disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group with an OhmTrak device<br>The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week. | Device: OhmTrak device.<br>* All probands will undergo six-week outpatient therapy once a week. The intervention group will be equipped with an OhmTrak device for home self-therapy and instructed in its correct use at least 5 times a week.<br>Other: Outpatient Physiotherapy<br>* All probands will undergo six-week outpatient therapy once a week for an hour<br>|
| Other: Group without an OhmTrak device<br>The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device. | Other: Outpatient Physiotherapy<br>* All probands will undergo six-week outpatient therapy once a week for an hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-abdominal pressure | Before the start and at the end of the six-weeks therapy, all probands will be blindly evaluated for the quality of activation and use of intra-abdominal pressure with the DNS Brace device. | six weeks | 
| Oswestry Disability Index, Version 2.1a | Before the start and at the end of the six-weeks therapy, all probands will fill in the Oswestry Disability Index questionnaire to evaluate their subjective state before and after a series of therapies. A score of zero equals no disability and a score of 100 is the maximum possible disability. | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-abdominal pressure, Biofeedback, Dynamometry