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

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05696249
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OhmTrak device.
  • Other: Outpatient Physiotherapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group with an OhmTrak device

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.
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
Other: Group without an OhmTrak device

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

Outcome Measures

Primary Outcome Measures

  1. Intra-abdominal pressure [six weeks]

    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.

  2. Oswestry Disability Index [six weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centrum Pohybove Medicina Pavla Kolare a.s. Prague Czechia 15800

Sponsors and Collaborators

  • Charles University, Czech Republic

Investigators

  • Study Director: Alena Kobesova, prof., Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine and FN Motol

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT05696249
Other Study ID Numbers:
  • EK - 1499/22
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Charles University, Czech Republic
Intra-abdominal pressure
Biofeedback
Dynamometry
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Jan 25, 2023