ESWT in LBP: clinical effect and postural stability

Not Applicable

• Conditions: low back pain.; M00-M99 Diseases of the musculoskeletal system and connective tissue

• Registration Number: IRCT20131001014844N1
• Lead Sponsor: Public Higher Medical Professional School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.