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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696249
• Other study ID #: EK - 1499/22
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Charles University, Czech Republic
• Contact: Martin Stribrny
• Phone: +420774630901
• Email: m.stribrny[@]seznam.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Czechia	Centrum Pohybove Medicina Pavla Kolare a.s.	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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