Clinical trial NCT05696249: The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients
Official title: The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Intra-abdominal pressure
Biofeedback
Dynamometry
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intra-abdominal pressure
timeFrame: six weeks
measure: Oswestry Disability Index, Version 2.1a
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Centrum Pohybove Medicina Pavla Kolare a.s.
Study officials:
affiliation: Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine and FN Motol
name: Alena Kobesova, prof.
role: STUDY_DIRECTOR
References: