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IRCT20131001014844N1 IRCT 2018-03-12 Public Higher Medical Professional School ESWT in LBP: clinical effect and postural stability Clinical effect and postural stability analysis of Extracorporeal Shock Wave Therapy (ESWT) in the treatment of Low Back Pain (LBP): randomized controlled trial 2639-06-09 anticipated 20 Pending https://irct.ir/trial/29401 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomisation using computer and envelopes, Blinding description: The participant will be blinded in the present study, where the probe will generate a sound signal, but the treatment parameters will be zeroed and the device will be turned off with a display system in "standby mode". N/A low back pain. Intervention 1: Intervention group: Patients from this group will receive a focused shockwave therapy utilising the radial type pneumatic device without anaesthesia. The low back area will receive a total of 2000 shocks during a session (5 Hz; 0.1 mJ/mm2; 2.5 bars). Each patient will have 10 sessions (twice a week) within 5 weeks. In addition, all patients will be supplemented with physical exercises performed throughout the therapy period. A single series will last 45 minutes daily and will be carried out five times a week (Monday to Friday). 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. Intervention 2: Control group: Patients from this group will receive a sham therapy (the probe will generate a sound signal, but the treatment parameters will be zeroed and the device will be turned off with a display system in "standby mode"). In addition, all patients will be supplemented with physical exercises (the same as in intervention group). Yes - There is a plan to make this available What will be shared: We are going to prepare a study website (when it will be registered) and enclose these documents When: When the first participant will be recruited and to the moment publishing results (when the articles will appear on WoS and PubMed) To whom: People, who will receive a password from the web moderator (registration process) Conditions: Analysed research data for registered persons Where to obtain: We will prepare a research website (to this date please use email addresses j.taradaj@awf.katowice.pl or karolina.w101@wp.pl) How to obtain: Standard registration process to receive login and password Comments:
public Karolina Walewicz
68 Katowicka St
Opole Poland 45-060 +48 77 442 35 50 karolina.w101@wp.pl Public Higher Medical Professional School scientific Karolina Walewicz
68 Katowicka St
Opole Poland 45-060 +48 77 442 35 50 karolina.w101@wp.pl Public Higher Medical Professional School Poland lumbosacral discopathy: the diagnosis of LBP will be based on MRI scans, which allow to 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). chronic pain syndrome with pseudo-radicular radiation without neurological impairment that have never had any prior spinal surgical intervention 18 years no limit Both acute and subacute spine pain episodes (up to 6 months) radicular pain syndrome degenerative changes on other segments of the spine: only initial, uncomplicated radiological changes (i.e., the 1st or the 2nd grade were allowed according to the Modic classification) past fractures within the spine tumors and hyperplastic changes spondylolisthesis rheumatic diseases cauda equina syndrome arrhythmia and implanted pacemake pregnancy in case of women chronic heart failure and peripheral vascular disease implanted metal implants skin diseases in the area of ESWT treatment superficial or deep sensory impairment mental disorders and addictions cancer psoriasis and other immunological diseases antibiotics and any analgesic, anti-inflammatory, or antithrombotic agent, damage of the vestibular system inflammation of the vestibular neuron or vestibulocochlear nerve disorder Meniere's disease dysfunction of the inner ear, and other diseases of the cerebellum, spinal cord, and brainstem M54.5 M00-M99 Diseases of the musculoskeletal system and connective tissue Treatment - Devices Rehabilitation Intervention group: Patients from this group will receive a focused shockwave therapy utilising the radial type pneumatic device without anaesthesia. The low back area will receive a total of 2000 shocks during a session (5 Hz; 0.1 mJ/mm2; 2.5 bars). Each patient will have 10 sessions (twice a week) within 5 weeks. In addition, all patients will be supplemented with physical exercises performed throughout the therapy period. A single series will last 45 minutes daily and will be carried out five times a week (Monday to Friday). 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. Control group: Patients from this group will receive a sham therapy (the probe will generate a sound signal, but the treatment parameters will be zeroed and the device will be turned off with a display system in "standby mode"). In addition, all patients will be supplemented with physical exercises (the same as in intervention group) The primary outcome will be an analysis of pain relief change and functional improvement in two groups of patients (within and intergroup comparisons). Timepoint: before and after therapy. Method of measurement: (1) the Visual-Analogue Scale (VAS), (2) the Laitinen Questionnaire Indicators of Pain (LQIP), (3) the Oswestry Disability Index (ODI), (4) the Roland–Morris Disability Questionnaire (RMDQ), (5) Lasegue’s Test (LT), (6) Schober’s Test (ST), (7) double-plate stabilometric platform compatible with a computer-aided posturographic system model CQ Stab 2P. The secondary outcome will be a follow-up observation (within and intergroup comparisons). Timepoint: 1 and 3 months after the end of the study. Method of measurement: (1) the Visual-Analogue Scale (VAS), (2) the Laitinen Questionnaire Indicators of Pain (LQIP), (3) the Oswestry Disability Index (ODI), (4) the Roland–Morris Disability Questionnaire (RMDQ), (5) Lasegue’s Test (LT), (6) Schober’s Test (ST), (7) double-plate stabilometric platform compatible with a computer-aided posturographic system model CQ Stab 2P. Public Higher Medical Professional School Approved 2638-04-26 The Research Ethics Committee from the Wroclaw Medical University 1 Pasteur St Wroclaw Lower Silesia Poland