Condition category
Musculoskeletal Diseases
Date applied
14/12/2018
Date assigned
30/01/2019
Last edited
30/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One of the most common causes of back pain disease is low back pain (LBP). Low back pain creates significant social and economic problems for many people. Approximately 60-80 % of people suffer from low back pain at least once in their life.. Our goal is to test how well works the rehabilitation in the treatment of these patients.

Who can participate
Adults with low back pain, who are patients of our Rehabilitation Institute.

What does the study involve
Our patients stay in our facility for 4-6 weeks. During these weeks they will get this treatment: all patients will receive at least five individual 30-minute rehabilitation exercise per week. They will also undergo twelve 30-minute group exercise sessions per week in a gymnasium and swimming pool. In addition patients will receive other therapies, i.e., electrotherapy, hydrotherapy, and massages.

Before and after the treatment we will measure some values using methods called posturography and plantography. All we need patients to do is to stay unsupported for 30 seconds. We will compare the results before and after treatment.

Patients will be also asked to label the level of the pain on the scale before and after the treatment.

What are the possible benefits and risks
Patients can benefit from this study by experiencing relief from the low back pain, body posture and stability improvement. Others may benefit in the future from the information we find in this study.

We don´t expect any direct risk to the patients.

Where is the study run from
Rehabilitation Institut Brandýs nad Orlicí, Czech republic.

When is the study starting and how long is it expected to run
01/01/2017 to 30/06/2018.

Who is funding the study
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Who is the main contact
Jiri Duchacek, sekretariat@rehabilitacniustav.cz, +420 465 544 207

Trial website

Contact information

Type

Public

Primary contact

Mr Jiří Ducháček

ORCID ID

Contact details

Lázeňská 58
Brandýs nad Orlicí
56112
Czech Republic
+420 465 544 207​
sekretariat@rehabilitacniustav.cz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3/2018

Study information

Scientific title

Efficacy of Rehabilitation Exercise and Treatment of Patients with Chronic Low Back Pain measured by posturography and plantography before and after the treatment

Acronym

Study hypothesis

Evaluation of efficacy of our special rehabilitation treatment (INFINITY Method) measured by posturography and plantography before and after the treatment

Ethics approval

Ethics Committee of the Rehabilitation Institute Brandys nad Orlici, 01/02/2017

Study design

Interventional, non-randomsied

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic low back pain

Intervention

All patients were hospitalized in our Rehabilitation Institute for 4-6 weeks and underwent:
1. At least five individual 30-minute special rehabilitation sessions per week
2. Six 30-minute group exercise sessions per week in a gymnasium and swimming pool

The INFINITY method is a rehabilitation approach based on neurophysiology, biomechanics, and anatomy. This Process encourages adjustment of the postural control system of the body, which gradually improves balance and symmetrization of the whole body in space, thus creating a precondition for better quality and more efficient movement. The rehabilitation is aimed at stabilizing, strengthening, and stretching of the thoracic, back, and abdominal muscles, including deep stabilizing system (DSS) with connection to diaphragmatic breathing. At the same time, the INFINITY method® enables increased mobility and flexibility via relaxation, stretching, mobilization and release of soft tissues of the musculoskeletal system. This rehabilitation approach uses active and passive exercises with supportive therapies including breathing exercises.

There was no participant follow-up.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Objective posturography will be measured using the following parameters at at the baseline and after 4 weeks of treatment:
1. Feet parallel, eyes open (cm)- area before 2.76, area after 2.23
2. Feet parallel, eyes closed (cm)- area before 3.09, area after 2.40

Secondary outcome measures

Subjective pain reduction will be measured using the visual analogue scale (VAS) at baseline and after 4 weeks of treatment.

Overall trial start date

01/01/2017

Overall trial end date

30/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Clinical diagnosis of low back pain
2. Confirmation of degenerative disease of lumbar spine by the MRI
3. The ability to stay unsupported for 30 seconds

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

331

Participant exclusion criteria

1. Immobile patients

Recruitment start date

30/06/2017

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Rehabilitation Institut Brandys nad Orlici
Lazenska 58
Brandys nad Orlici
56112
Czech Republic

Sponsor information

Organisation

Rehabilitation Institut Brandys nad Orlici

Sponsor details

Lazenska 58
Brandys nad Orlici
56112
Czech Republic
+420 465 544 031
sekretariat@rehabilitacniustav.cz

Sponsor type

Hospital/treatment centre

Website

https://www.rehabilitacniustav.cz/cs

Funders

Funder type

Hospital/treatment centre

Funder name

Rehabilitation Institut Brandys nad Orlici

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes