NCT05696249

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	OhmTrak 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.
OTHER	Outpatient Physiotherapy	All probands will undergo six-week outpatient therapy once a week for an hour

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2023-01-25
• Last updated: 2023-02-09

Locations

1 site across 1 country: Czechia