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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05696249
Enrollment
40
Registered
2023-01-25
Start date
2023-01-01
Completion date
2023-06-30
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

Keywords

Intra-abdominal pressure, Biofeedback, Dynamometry

Brief summary

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.

Interventions

DEVICEOhmTrak device.

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.

All probands will undergo six-week outpatient therapy once a week for an hour

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intra-abdominal pressuresix weeksBefore 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.
Oswestry Disability Index, Version 2.1asix weeksBefore 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.

Countries

Czechia

Contacts

Primary ContactMartin Stribrny
m.stribrny@seznam.cz+420774630901
Backup ContactVilma Kralova
kralova.vilma@gmail.com+420777625226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026