Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001416189
Ethics application status
Approved
Date submitted
4/06/2019
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Usefulness of static posturography with reference to established subjective clinical examination
Scientific title
Postural stability in patients with osteoarthritis of the lumbosacral spine using posturography
Secondary ID [1] 295325 0
none
Universal Trial Number (UTN)
U1111-1216-3305
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 308524 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307494 307494 0 0
Physiotherapy
Neurological 311781 311781 0 0
Other neurological disorders
Musculoskeletal 312179 312179 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study group will be consisted of randomly selected patients of both sexes, undergoing treatment for lumbosacral discogenic pain syndrome due to degenerative spondyloarthropathy, with no history of hip or knee osteoarthritis, as the latter could manifest with pain radiating to the lumbosacral segment of the spine. The diagnosis will be established based on medical history, physical examination, and radiographic assessments (anteroposterior and lateral X-ray films, magnetic resonance imaging, or computed tomography).

All study subjects will be underwent static posturography, rated their pain severity based on a visual analog scale (VAS), and had their physical functioning will be evaluated with a modified WOMAC questionnaire. These assessments will be conducted in the morning on the first and final days of the rehabilitation course, before the rehabilitation treatments scheduled for those days, and after approximately three months (± 2 weeks) after rehabilitation course completion.
The study group will be underwent a 15-day course of physiotherapy, including: relaxation-promoting positioning- reducing load on the lumbosacral
spine by a system of slings with knees and hips bending to angle of 90 degrees (about 30 min. once daily,the duration of administration, 3 weeks) , magnetotherapy (frequency with f=2-50Hz, field intensity of 2.5-5 mT
and duration of 15 minutes, once daily,the duration of administration, 3 weeks), hydrocortisone iontophoresis at the trigger point in the lumbosacral region(2% hydrocortisonum, once daily,the duration of administration, 3 weeks) , interferential current (f=1–100 Hz) , special exercises for strengthening core and lower extremity muscles, intended for patients with spondyloarthropathies, isometric exercises, general fitness exercises, proprioception exercises for the lower extremities and spine, water exercises-about 30 min. once daily,the duration of administration, 3 weeks and patient education on preventing low back overload -
guidance on prevention of low back pain for example in work, sitting position, activities of daily living etc. Education will be provided in whole 15-day course of physiotherapy on each session. It will be provided by certificated physiotherapist with PhD or MSc degree.
Participants with osteoarthritis of the lumbosacral spine will be patients of the Department of Rehabilitation of the Independent Public Central Clinical Hospital in Warsaw.

Pedobarographic measurements will be collected using a WIN-POD Pel 38 electronic podometer and WIN-POD 3.81 software at a frequency (f) of 100 Hz per 30 seconds. To ensure uniform data collection and reliable results, examiners will be asked to adhere to a strict study protocol that included asking participants a series of questions prior to the test about conditions that could adversely affect postural stability. The questions will be designed to assess overall well-being, medication intake, number of hours of sleep, alcohol consumption, history of excessive physical exercise, and current pain or discomfort.

The examination will be consisted of four, 30-second tests with 60-second intermissions in the sitting position. The first two pedobarographic tests will be performed with eyes open (EO) in freestanding posture, whereas the third and fourth tests will be performed with eyes closed (EC). The participants will be asked to remove their shoes and stand upright on the forceplate with the head erect and their arms hanging loosely by their sides. Also they will be asked to stand (barefoot) on a floor-based foot pressure measurement device as pedobarographic balance measurements of deviation length, area and velocity from center of gravity will be recorded. All tests will be conducted in a quiet room with normal temperature and the same illumination.

WIN-POD electronic podometer will be calibrated prior to the recordings and further underwent an automatic calibration check before each trial.
Intervention code [1] 301651 0
Rehabilitation
Comparator / control treatment
The study group will be also control group for themselves (it will be the same subjects).
A posturographic evaluation, pain severity based on a visual analog scale (VAS), and had their physical functioning evaluated with a modified WOMAC questionnaire will be performed immediately before (1st day of treatment) and after rehabilitaton (15th day of treatment) and at three months after completion of the treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306467 0
The primary outcome will be changes in postural stability (body stability)
Pedobarographic measurements will be collected using a WIN-POD Pel 38 electronic podometer and WIN-POD 3.81 software at a frequency (f) of 100 Hz per 30 seconds.
The examination will be consisted of four, 30-second tests with 60-second intermissions in the sitting position. The first two pedobarographic tests will be performed with eyes open (EO) in freestanding posture, whereas the third and fourth tests will be performed with eyes closed (EC). The participants will be asked to remove their shoes and stand upright on the forceplate with the head erect and their arms hanging loosely by their sides. Also they will be asked to stand (barefoot) on a floor-based foot pressure measurement device as pedobarographic balance measurements of deviation length, area and velocity from center of gravity will be recorded. All tests will be conducted in a quiet room with normal temperature and the same illumination.
Pedobarographic assessment will be taken three times: before treatment, immedenty after and three months (± 2 weeks) after rehabilitation course completion
Timepoint [1] 306467 0

first and final days of the rehabilitation course, before the rehabilitation treatments scheduled for those days, and after approximately three months (± 2 weeks) after rehabilitation course completion.
Secondary outcome [1] 348630 0
Secondary outcome will be also assessed functional capabilities.

Functional capabilities will be classified according WOMAC questionnaire
Timepoint [1] 348630 0
first and final days of the rehabilitation course, before the rehabilitation treatments scheduled for those days, and after approximately three months (± 2 weeks) after rehabilitation course completion.
Secondary outcome [2] 374873 0
Pain severity will be also assessed.

Severity of pain will be classified according to Visual Analogue Scale (VAS).
Timepoint [2] 374873 0
first and final days of the rehabilitation course, before the rehabilitation treatments scheduled for those days, and after approximately three months (± 2 weeks) after rehabilitation course completion.

Eligibility
Key inclusion criteria
diagnosed lumbosacral discogenic pain syndrome due to degenerative spondyloarthropathy
confirmed consent agree to participate in study
pain severity based on a visual analog scale (VAS) >4
a positive lasegue's test (also called straight leg raise, SLR test)
not consumption of analgesic, psychotropic or other medicines that could affect equilibrium responses
Minimum age
30 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
musculoskeletal pain, advanced foot deformities, intake of analgesic drugs, functional shortening of more than 15 mm of a lower limb,balance disorder,overall poor well-being, pregmancy, declared consumption of alcohol within 24 hours of the test and less than 6 hours of sleep, single/total hip or knee arthroplasty.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been computed as follows. We assumed the effect size d=0.57, a err prob = 0.05 and minimum power (1-ß err prob) = 0.8. For the computation of the effect size we took empirical values of mean and standard deviation (SD) for area of displacement of the center of pressure (ACoP) and the average speed of displacement of the center of pressure (VCoP)based on the previous studies [1] - value of mean (ACoP) = 1.59 and SD = 0.93 for the VCoP= 5.14 SD= 0.95.

We assumed that the ratio of the t1 group to the control group (allocation ratio) should be 1.0. Computations made with the G*Power 3.0.10 software resulted in the minimum sample size for the treatment group equal to 49 and for the control group equal to 49.

statistical assumptions prepared based on the previous studies [1] "Comparison of static postural balance between healthy subjects and those with low back pain" Acta Ortop Bras. 2012; 20(4): 210–212.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2019
Actual
Date of last participant enrolment
Anticipated
28/01/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
49
Accrual to date
Final
Recruitment outside Australia
Country [1] 10589 0
Poland
State/province [1] 10589 0
warsaw

Funding & Sponsors
Funding source category [1] 299915 0
Self funded/Unfunded
Name [1] 299915 0
Country [1] 299915 0
Primary sponsor type
Individual
Name
Bartosz Slomka
Address
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw,Banacha 1a, 02-097, Warsaw, Poland
Country
Poland
Secondary sponsor category [1] 299282 0
Individual
Name [1] 299282 0
Witold Rongies
Address [1] 299282 0
Department of Rehabilitation, Faculty of Medicine,
Medical University of Warsaw, Poland
Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country [1] 299282 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300784 0
Bioethics Committee of the Medical University of Warsaw
Ethics committee address [1] 300784 0
Zwirki i Wigury 61, 02-091 Warsaw,
Ethics committee country [1] 300784 0
Poland
Date submitted for ethics approval [1] 300784 0
07/01/2013
Approval date [1] 300784 0
12/01/2013
Ethics approval number [1] 300784 0
KB/36/2013

Summary
Brief summary
Background. Spinal pain syndrome, commonly referred to as low back pain, is a scourge of our times.
Objective. The aim of the study will be evaluate the usefulness of static posturography in monitoring the progress of rehabilitation in a group of patients with lumbosacral pain syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55518 0
Dr Bartosz Slomka
Address 55518 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Poland
Banacha 1a, 02-097, Warsaw, Poland
Country 55518 0
Poland
Phone 55518 0
+48 022 57 20 920
Fax 55518 0
Email 55518 0
slomka.bartosz@interia.pl
Contact person for public queries
Name 55519 0
Prof Witold Rongies
Address 55519 0
Department of Rehabilitation, Faculty of Medicine,
Medical University of Warsaw, Poland
Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country 55519 0
Poland
Phone 55519 0
+48 022 57 20 920
Fax 55519 0
Email 55519 0
slomka.bartosz@interia.pl
Contact person for scientific queries
Name 55520 0
Dr Bartosz Slomka
Address 55520 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Poland
Banacha 1a, 02-097, Warsaw, Poland
Country 55520 0
Poland
Phone 55520 0
+48 022 57 20 920
Fax 55520 0
Email 55520 0
slomka.bartosz@interia.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2253Ethical approval    368115-(Uploaded-04-06-2019-04-40-55)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.