None listed
Conditions
Brief summary
The ESWT in the treatment of musculoskeletal problems still cause much confusion and controversy. The critical review of databases (PEDro, MEDLINE, PubMed, Scopus, and Web of Science Core Collection) shows the evaluation the effectiveness of shock wave based only on subjective (ADL and pain feeling scales, questionnaires etc.), imperfect tests in terms of measurement error, weak clinical studies without placebo/sham therapy and follow-ups. The purpose of this study is to assess clinical efficiency in use of the various tools from subjective to objective in participants with chronic low back pain after ESWT on the analysis of short-term and long-term results and with a comparison to the placebo effect.
Interventions
The objective of this study is to assess the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and to compare verum (2000 pneumatic shocks during a 20 minutes session of 5 Hz; 0.1 mJ/mm2; 2.5 bars) to sham procedure 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). Intervention: Patients from group A will receive a focused shockwave therapy utilising the radial type pneumatic device without anaesthesia. The intervention will occur in the clinician's office and be administered by certified physiotherapist. 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. Patients from group B 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 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. The physical exercises will occur "one-on-one" method in the gym part of clinician's office and be administered by 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).
Sponsors
Study design
Eligibility
Inclusion criteria
Participants with lumbosacral discopathy and chronic pain syndrome with pseudo-radicular radiation without neurological impairment that have never had any prior spinal surgical intervention will be included in the study. 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).
Exclusion criteria
The exclusion criteria will be: (1) acute and subacute spine pain episodes (up to 6 months), (2) radicular pain syndrome, (3) 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), (4) past fractures within the spine, (5) tumors and hyperplastic changes, (6) spondylolisthesis, (7) rheumatic diseases, (8) cauda equina syndrome, (9) pregnancy in case of women, (10) chronic heart failure and peripheral vascular disease, (11) arrhythmia and implanted pacemaker, (12) implanted metal implants, (13) skin diseases in the area of shock wave treatment, (14) superficial or deep sensory impairment, (15) mental disorders and addictions, (16) cancer, (17) psoriasis and other immunological diseases, (18) infections, (19) antibiotics and any analgesic, anti-inflammatory, or antithrombotic agent, (20) damage of the vestibular system, (21) inflammation of the vestibular neuron or vestibulocochlear nerve disorder, (22) Meniere's disease, (23) dysfunction of the inner ear, and other (24) diseases of the cerebellum, spinal cord, and brainstem.