None listed
Conditions
Brief summary
Background and study aims Low back pain (LBP) is one of the most common disabling health conditions worldwide. LBP is a disease resulting from the development of modern society. Evolution, as a result of which a person has adopted a vertical position of the body and the spread of a sedentary lifestyle contributes to the formation of balance disorders - both static and dynamic, and the occurrence of low back pain. This is an increasingly common problem that leads to a decrease in the quality of life, often disrupting the proper functioning of the whole organism, which affects large restrictions in professional and social life. Radiofrequency is an alternative medicine technique in low back pain. The objective of this study is to assess the effectiveness of radiofrequency therapy and to compare real procedures to sham procedures 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).
Interventions
The objective of this study is to assess the effectiveness of radiofrequency therapy and to
compare real procedures to sham procedures in the treatment of low back pain.
Participants will be randomised to receive radiofrequency or placebo therapy,
Patients from group A will receive a radiofrequency therapy that includes application within low back (the active parameters: frequency 448 kHz, energy level 12-20 W, session duration 15 minutes).
Patients from group B will receive a sham therapy wh
The objective of this study is to assess the effectiveness of radiofrequency therapy and to compare real procedures to sham procedures in the treatment of low back pain. Participants will be randomised to receive radiofrequency or placebo therapy, Patients from group A will receive a radiofrequency therapy that includes application within low back (the active parameters: frequency 448 kHz, energy level 12-20 W, session duration 15 minutes). Patients from group B will receive a sham therapy which voided of active components by applying a special applicator cap, which absorbed energy and limited its propagation to the human tissues (session duration 15 minutes). During the therapy, there will be constant supervision of the patient and observation of the patient for 15 minutes after the intervention. Each patient from two groups will have 10 sessions (twice a week) within 5 weeks. The intervention will occur in the clinician's office and be administered by certified physiotherapist and naturopathic practitioner. In addition, all patients will be supplemented with physical exercises performed throughout the therapy period. A single exercise series will last 45 minutes daily and will be carried out five times a week (Monday to Friday) for 5 weeks. 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 a 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
Institute of Health Sciences, University of Opole, Poland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant 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
Participant exclusion criteria 1. Radicular pain syndrome 2. Past fractures within the spine 3. Cancer, tumors and hyperplastic changes 4. Spondylolisthesis 5. Rheumatic diseases 6. Cauda equina syndrome 7. Pregnancy in case of women 8. Chronic heart failure and peripheral vascular disease 9. Arrhythmia and implanted pacemaker 10. Implanted metal implants 11. Dermatological conditions in the area treatment 12. Superficial or deep sensory impairment 13. Mental disorders 14. Infections 15. Any analgesic, anti-inflammatory 16. Damage of the vestibular system 17. Inflammation of the vestibular neuron or vestibulocochlear nerve disorder 18. Meniere's disease 19. Dysfunction of the inner ear 20. Other diseases of the cerebellum, spinal cord, and brainstem
Outcome results
None listed