Chronic Low-back PainNCT05696249
The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients
A study testing OhmTrak device. and Outpatient Physiotherapy in people with Chronic Low-back Pain, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- OhmTrak device. and Outpatient Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with chronic Low Back Pain
- age range of 30-65 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Centrum Pohybove Medicina Pavla Kolare a.s.
Prague, 15800
Martin Stribrny, +420774630901, m.stribrny@seznam.cz
Jakub Jacisko, MUDr.
About this study
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- OhmTrak device., Outpatient Physiotherapy
- Keywords
- Intra-abdominal pressure, Biofeedback, Dynamometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Outpatient PhysiotherapyOther
All probands will undergo six-week outpatient therapy once a week for an hour
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Outpatient Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Jan 2023
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alena Kobesova, prof., Study director, Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine and FN Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696249
- Sponsor's protocol ID
- EK - 1499/22
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Pressure Sensors in Functional Assessment and Treatment of Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05696249
- Acronym / sponsor ID
- EK - 1499/22
- Conditions
- Chronic Low-back Pain
- Keywords
- Intra-abdominal pressure, Biofeedback, Dynamometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with an OhmTrak device | Experimental | Device: OhmTrak device., Other: Outpatient PhysiotherapyThe 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 without an OhmTrak device | Other | Other: Outpatient PhysiotherapyThe control group will receive identical outpatient therapy and instruction in self-therapy, except they will not have access to the OhmTrak device. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with chronic Low Back Pain
- age range of 30-65 years.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group with an OhmTrak device |
| Outpatient PhysiotherapyAll probands will undergo six-week outpatient therapy once a week for an hour | Other | Group with an OhmTrak device, Group without an OhmTrak device |
Primary outcome
Intra-abdominal pressure
Time frame: 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.
Oswestry Disability Index, Version 2.1a
Time frame: 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. A score of zero equals no disability and a score of 100 is the maximum possible disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alena Kobesova, prof. study director
Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine and FN Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OhmTrak device. and Outpatient Physiotherapy in people with Chronic Low-back Pain, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Stribrny (+420774630901, m.stribrny@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-abdominal pressure (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.