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Trial registered on ANZCTR
Registration number
ACTRN12625000512426
Ethics application status
Approved
Date submitted
14/02/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of effectiveness of radiofrequency therapy performed on low back pain
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Scientific title
Comparison of the Effectiveness of Radiofrequency Therapy on Clinical Outcomes, Postural Control, and Gait in the Treatment of Low Back Pain: Short- and Long-Term Results in participants with lumbosacral discopathy and chronic pain syndrome
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Secondary ID [1]
313963
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low back pain
336684
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Condition category
Condition code
Physical Medicine / Rehabilitation
333185
333185
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0
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Physiotherapy
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Musculoskeletal
333186
333186
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The objective of this study is to assess the effectiveness of radiofrequency therapy and to
compare real procedures to sham procedures in the treatment of low back pain.
Participants will be randomised to receive radiofrequency or placebo therapy,
Patients from group A will receive a radiofrequency therapy that includes application within low back (the active parameters: frequency 448 kHz, energy level 12-20 W, session duration 15 minutes).
Patients from group B will receive a sham therapy which voided of active components by applying a special applicator cap, which absorbed energy and limited its propagation to the
human tissues (session duration 15 minutes).
During the therapy, there will be constant supervision of the patient and observation of the patient for 15 minutes after the intervention.
Each patient from two groups will have 10 sessions (twice a week) within 5 weeks. The
intervention will occur in the clinician's office and be administered by certified physiotherapist and naturopathic practitioner.
In addition, all patients will be supplemented with physical exercises performed throughout the therapy period. A single exercise series will last 45 minutes daily and will be carried out five times a week (Monday to Friday) for 5 weeks.
Stabilization training will include:
- Techniques for the relaxation of the myofascial system on erector spinae muscle,
- Techniques for activating the neutral position of the lumbo-pelvic-hip complex and deep
muscles,
- Stimulation of proper breathing and correct activation of the transverse abdominal muscle,
- Coordination of superficial and deep muscles activation,
- Postural and dynamic training.
The physical exercises will occur "one-on-one" method in the gym part of clinician's office and be administered by a certified athletic therapist. The training will be with the participants' intensity of 65-75% maximal heart rate (to monitor the application of exercises and the participants' status; the therapist observation diary will be kept).
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Intervention code [1]
330554
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Rehabilitation
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Intervention code [2]
330965
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Treatment: Devices
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Intervention code [3]
330966
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Treatment: Other
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Comparator / control treatment
Patients from control group will receive a sham therapy which voided of active components by applying a special applicator cap, which absorbed energy and limited its propagation to the human tissues (session duration 15 minutes).
Each patient from control group will have 10 sessions (twice a week) within 5 weeks. The
intervention will occur in the clinician's office and be administered by certified physiotherapist and naturopathic practitioner.
Will be treated with kinesitherapy, a single exercise series will last 45 minutes daily and will be carried out five times a week (Monday to Friday), the same as in the study group.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Assessment of pain symptoms
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Assessment method [1]
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The VAS (Visual Analogue Scale) pain assessment scale was used for subjective assessment of the experienced pain, in which the patient assesses the experienced pain on a simple scale from 0 to 10, where 0 denotes lack of pain and 10 de- notes the strongest pain.
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Timepoint [1]
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The primary endpoint: before (baseline) and after therapy (week 5, primary time point), additionally 1 and 3 months after the end of the study.
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Primary outcome [2]
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Assessment of pain symptoms
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Assessment method [2]
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Laitinen Pain Indicator Questionnaire
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Timepoint [2]
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The primary endpoint: before (baseline) and after therapy (week 5, primary time point), additionally 1 and 3 months after the end of the study.
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Primary outcome [3]
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Functional efficiency assessment
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Assessment method [3]
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Oswestry Disability Index (ODI)
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Timepoint [3]
340751
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The primary endpoint: before (baseline) and after therapy (week 5, primary time point), additionally 1 and 3 months after the end of the study
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Secondary outcome [1]
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Functional efficiency assessment
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Assessment method [1]
444990
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Roland–Morris Disability Questionnaire (RMDQ)
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Timepoint [1]
444990
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Before (baseline) and after therapy (week 5) and also 1 and 3 months after the end of study
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Secondary outcome [2]
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Evaluation of mobility of the lumbosacral spine.
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Assessment method [2]
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Schober Test While the patient is in a standing position, the examiner marks 2 points on the patient’s skin: at 10 cm above the line connecting the posterior superior iliac spines, and then at 5 cm below that line. The patient then slowly bends down as far as possible, while keeping the knees straight. The measurement is made using a tape measure.
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Timepoint [2]
444991
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Before (baseline) and after therapy (week 5) and also 1 and 3 months after the end of study
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Secondary outcome [3]
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Measure the mobility range in the hip joint
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Assessment method [3]
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Lasque Test The starting position is lying down on the back with both legs straight. The examiner then slowly lifts one of the patient’s legs while the knee is straight at the joint until pain occurs. The mobility range is measured in angle degrees using a goniometer.
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Timepoint [3]
444992
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Before (baseline) and after therapy (week 5) and also 1 and 3 months after the end of study
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Secondary outcome [4]
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Posturography analysis the position of posture with open and closed eyes. (COP)
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Assessment method [4]
444994
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Platform from AMTI AccuGait (Advanced Mechanical Technology Inc., USA) with Balance Clinic computer software was used to assess clinical outcomes objectively. The device was used to assess parameters evaluating posture.
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Timepoint [4]
444994
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Before (baseline) and after therapy (week 5) and also 1 and 3 months after the end of study
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Secondary outcome [5]
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Analysis of gait parameters
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Assessment method [5]
444995
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Platform from AMTI AccuGait (Advanced Mechanical Technology Inc., USA) with Balance Clinic computer software was used to assess clinical outcomes objectively.
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Timepoint [5]
444995
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Before (baseline) and after therapy (week 5) and also 1 and 3 months after the end of study
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Eligibility
Key inclusion criteria
Participant inclusion criteria
1. Lumbosacral discopathy and chronic pain syndrome with pseudo-radicular radiation without neurological impairment
2. Never had any prior spinal surgical intervention
3. Diagnosis of LBP based on MRI scans, which clearly show the advancement of degenerative changes at the L5-S1 spine segment (the inclusion criterion was at least the 3rd grade in the Modic classification)
4. Aged 18 years or above
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participant exclusion criteria
1. Radicular pain syndrome
2. Past fractures within the spine
3. Cancer, tumors and hyperplastic changes
4. Spondylolisthesis
5. Rheumatic diseases
6. Cauda equina syndrome
7. Pregnancy in case of women
8. Chronic heart failure and peripheral vascular disease
9. Arrhythmia and implanted pacemaker
10. Implanted metal implants
11. Dermatological conditions in the area treatment
12. Superficial or deep sensory impairment
13. Mental disorders
14. Infections
15. Any analgesic, anti-inflammatory
16. Damage of the vestibular system
17. Inflammation of the vestibular neuron or vestibulocochlear nerve disorder
18. Meniere's disease
19. Dysfunction of the inner ear
20. Other diseases of the cerebellum, spinal cord, and brainstem
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to the groups. Computer-generated random numbers will be sealed in sequentially numbered envelopes, and the group allocation be independent of the time and person delivering the treatment. The physician (research coordinator) who will allocate the subjects to groups have envelopes, each containing a piece of paper marked with either group A or B The physician will select and open an envelope in the presence of a physiotherapist to see the symbol and then direct the patient to the corresponding group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer and numbered envelopes
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Statistical analysis
Statistical analysis was performed using Statistica 13 (TIBCO, Inc., USA). For measurable variables, arithmetic means, medians, standard deviations, quartiles and the range of variability (extreme values) were calculated. Frequencies were calculated for qualitative variables (results are given in percentages). Quantitative variables were checked with the Shapiro-Wilk test to determine the type of distribution. Comparison of qualitative variables between groups was made using the chi-square test (?2). Intragroup comparison between results was performed using Friedman's analysis of variance and post-hoc test (Dunn's test). Finally, the comparison of results between the study group and placebo was assessed using the Mann-Whitney U-test. The level of a=0.05 was used for all comparisons.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
30/01/2025
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Date of last participant enrolment
Anticipated
15/06/2025
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Actual
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Date of last data collection
Anticipated
15/12/2025
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Actual
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Sample size
Target
80
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Accrual to date
6
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Final
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Recruitment outside Australia
Country [1]
26892
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Poland
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State/province [1]
26892
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Opole
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Funding & Sponsors
Funding source category [1]
318461
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University
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Name [1]
318461
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University of Opole
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Address [1]
318461
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Country [1]
318461
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Poland
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Primary sponsor type
University
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Name
Institute of Health Sciences, University of Opole, Poland
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Address
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Country
Poland
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Secondary sponsor category [1]
320861
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None
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Name [1]
320861
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Address [1]
320861
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Country [1]
320861
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317076
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Ethics Committee from the Public Higher Medical Professional School in Opole
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Ethics committee address [1]
317076
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(68 Katowicka St, Opole, 45-060, Poland; +48 601 444 943; biurorektora@wsm.opole.pl)
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Ethics committee country [1]
317076
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Poland
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Date submitted for ethics approval [1]
317076
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01/07/2019
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Approval date [1]
317076
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02/09/2019
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Ethics approval number [1]
317076
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KB/193/FI/2019
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Summary
Brief summary
Background and study aims Low back pain (LBP) is one of the most common disabling health conditions worldwide. LBP is a disease resulting from the development of modern society. Evolution, as a result of which a person has adopted a vertical position of the body and the spread of a sedentary lifestyle contributes to the formation of balance disorders - both static and dynamic, and the occurrence of low back pain. This is an increasingly common problem that leads to a decrease in the quality of life, often disrupting the proper functioning of the whole organism, which affects large restrictions in professional and social life. Radiofrequency is an alternative medicine technique in low back pain. The objective of this study is to assess the effectiveness of radiofrequency therapy and to compare real procedures to sham procedures in the treatment of low back pain. The primary study endpoints will be an analysis of pain relief change and functional improvement in two groups of patients (within and intergroup comparison before and after therapy). The secondary endpoints will be a follow-up observation (1 and 3 months after the end of the study - within and intergroup comparisons).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Joanna Rajfur
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Address
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Institute of Health Sciences, University of Opole, Poland, Opole 45-060 Katowicka 68 street
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Country
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Poland
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Phone
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+48 504834267
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Fax
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Email
139922
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[email protected]
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Contact person for public queries
Name
139923
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Joanna Rajfur
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Address
139923
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Institute of Health Sciences, University of Opole, Poland, Opole 45-060 Katowicka 68 street
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Country
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Poland
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Phone
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+48 504834267
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Katarzyna Rajfur
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Address
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Institute of Health Sciences, University of Opole, Poland, Opole 45-060 Katowicka 68 street
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Country
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Poland
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Phone
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+48 506202372
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Fax
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Email
139924
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Supervisor decision.
What supporting documents are/will be available?
No Supporting Document Provided
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.
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