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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women

NCT02103036

Low Back Pain

UNKNOWN NA

Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain

NCT06399497

Low Back Pain

NOT_YET_RECRUITING NA

The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain

NCT06554236

Low Back Pain

NOT_YET_RECRUITING NA

Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality

NCT02729181

Low Back Pain

COMPLETED

Telerehabilitation-based Exercises vs Standard Home-based Exercise in Low Back Pain

NCT06446596

Low Back Pain

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low-back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

OhmTrak device.

Intervention Type 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.

Outpatient Physiotherapy

Intervention Type OTHER

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

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.

Group Type OTHER

Outpatient Physiotherapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Outpatient Physiotherapy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No