Rehabilitation treatment in patients with back pain

ISRCTN	ISRCTN13484642
DOI	https://doi.org/10.1186/ISRCTN13484642
Secondary identifying numbers	3/2018

Submission date: 14/12/2018
Registration date: 30/01/2019
Last edited: 30/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Jiří Ducháček
Public

Lázeňská 58
Brandýs nad Orlicí
56112
Czech Republic

Phone	+420 465 544 207
Email	sekretariat@rehabilitacniustav.cz

Study information

Study design	Interventional, non-randomsied
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
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
Study objectives	Evaluation of efficacy of our special rehabilitation treatment (INFINITY Method) measured by posturography and plantography before and after the treatment
Ethics approval(s)	Ethics Committee of the Rehabilitation Institute Brandys nad Orlici, 01/02/2017
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2017
Completion date	30/06/2018

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	331
Key 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
Key exclusion criteria	1. Immobile patients
Date of first enrolment	30/06/2017
Date of final enrolment	31/10/2017

Locations

Countries of recruitment

Czech Republic

Study participating centre

Rehabilitation Institut Brandys nad Orlici

Lazenska 58
Brandys nad Orlici
56112
Czech Republic

Sponsor information

Rehabilitation Institut Brandys nad Orlici
Hospital/treatment centre

Lazenska 58
Brandys nad Orlici
56112
Czech Republic

Phone	+420 465 544 031
Email	sekretariat@rehabilitacniustav.cz
Website	https://www.rehabilitacniustav.cz/cs

Funders

Funder type

Hospital/treatment centre

Rehabilitation Institut Brandys nad Orlici

No information available

Results and Publications

Intention to publish date	30/06/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.