NCT05696249

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

January 8, 2023

Last Update Submit

February 7, 2023

Conditions

Chronic Low-back Pain

Keywords

Intra-abdominal pressureBiofeedbackDynamometry

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group with an OhmTrak device

EXPERIMENTAL

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.

Device: OhmTrak device.Other: Outpatient Physiotherapy

Group without an OhmTrak device

OTHER

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

Other: Outpatient Physiotherapy

Interventions

OhmTrak device.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.

Group with an OhmTrak device
Outpatient PhysiotherapyOTHER

All probands will undergo six-week outpatient therapy once a week for an hour

Group with an OhmTrak deviceGroup without an OhmTrak device

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with chronic Low Back Pain
  • age range of 30-65 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Pohybove Medicina Pavla Kolare a.s.

Prague, 15800, Czechia

RECRUITING

Study Officials

  • Alena Kobesova, prof.

    Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine and FN Motol

    STUDY DIRECTOR

Central Study Contacts

Martin Stribrny

CONTACT

+420774630901m.stribrny@seznam.cz

Vilma Kralova

CONTACT

+420777625226kralova.vilma@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 25, 2023

Study Start

January 1, 2023

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)