low back pain. M00-M99 Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
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 t
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 se
- 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 zeroe
Sponsors
Public Higher Medical Professional School
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Poland
Contacts
Public ContactKarolina Walewicz
Public Higher Medical Professional School
Outcome results
None listed