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

Charles University, Czech Republic

Status: Enrolling

Conditions: Chronic Low-back Pain

Treatments: Device: OhmTrak device.; Other: Outpatient Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05696249

EK - 1499/22

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group with an OhmTrak device

Experimental group

Description:

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.

Treatment:

Device: OhmTrak device.

Other: Outpatient Physiotherapy

Group without an OhmTrak device

Other group

Description:

The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device.

Treatment:

Other: Outpatient Physiotherapy