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

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
OhmTrak device.
Outpatient Physiotherapy
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Intra-abdominal pressure, Biofeedback, Dynamometry

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centrum Pohybove Medicina Pavla Kolare a.s.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group with an OhmTrak device

Group without an OhmTrak device

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2023
Last Updated
February 7, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05696249
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Intra-abdominal pressure, Biofeedback, Dynamometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group with an OhmTrak device
Arm Type
Experimental
Arm 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.
Arm Title
Group without an OhmTrak device
Arm Type
Other
Arm Description
The control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device.
Intervention Type
Device
Intervention Name(s)
OhmTrak device.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Outpatient Physiotherapy
Intervention Description
All probands will undergo six-week outpatient therapy once a week for an hour
Primary Outcome Measure Information:
Title
Intra-abdominal pressure
Description
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.
Time Frame
six weeks
Title
Oswestry Disability Index, Version 2.1a
Description
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.
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Stribrny
Phone
+420774630901
Email
m.stribrny@seznam.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Vilma Kralova
Phone
+420777625226
Email
kralova.vilma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alena Kobesova, prof.
Organizational Affiliation
Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine and FN Motol
Official's Role
Study Director
Facility Information:
Facility Name
Centrum Pohybove Medicina Pavla Kolare a.s.
City
Prague
ZIP/Postal Code
15800
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Stribrny
Phone
+420774630901
Email
m.stribrny@seznam.cz
First Name & Middle Initial & Last Name & Degree
Jakub Jacisko, MUDr.
First Name & Middle Initial & Last Name & Degree
Martin Stribrny, Mgr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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