Chronic low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
Patients from group A will receive a DN therapy that includes needles application within low back, buttocks and thighs area.
Patients from group B will receive a sham therapy with usage of specialist
- 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
the therapist observation diary will be kept).
Participants will be randomized with equal probability to real or placebo group using a central computer-generated random allocation. Subjects will be r
Sponsors
Public Higher Medical Professional School in Opole
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 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 24. Other diseases of the cerebellum, spinal cord, and brainstem 25. Fear of needles
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain assessed with the Visual-Analogue Scale (VAS) and the Laitinen Pain Indicator Questionnaire before (baseline) and after therapy (week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Before (baseline) and after therapy (week 4) and also 1 and 3 months after the end of study: 1. Quality of life assessed with the Roland–Morris Disability Questionnaire (RMDQ) 2. Posturography used to analyze the position of posture with open and closed eyes 3. Medical treadmill used to analyze gait 4. The Lasègue test used to measure the mobility range in the hip joint on the side of the herniated disc in the course of spinal discopathy. 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 5. The Schober test used for evaluation of mobility of the lumbosacral spine. 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. The obtained result is recorded with an accuracy of up to 0.5 cm 6. Pain assessed with the Visual-Analogue Scale (VAS) and the Laitinen Pain Indicator Questionnaire | — |
Countries
Poland
Outcome results
None listed