Low back pain and degenerative spinal disorders Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 13/11/2025: 1. European 2. Adult men and women from 25 to 60 years old 3. Residual pain syndrome is older than 6 months but less than 3 years after DLSS decompression surgery 4. Localization of the maximum pain syndrome in the lumbosacral joint 5. The severity of residual pain by visual analogue scale (VAS) is 6 scores and higher 6. Signed voluntary informed consent to participate in this study Previous inclusion criteria: 1. European 2. Adult men and women from 25 to 60 years old 3. Residual pain syndrome is older than 6 months but less than 3 years after DLSS decompression surgery 4. Localization of the maximum pain syndrome in the lumbosacral joint 5. The severity of residual pain by visual analogue scale (VAS) is 6 scores and higher 6. DLSS decompression surgery was completed without complications and without significant negative dynamics according to magnetic resonance imaging (MRI) and electroneuromyography (ENMG) data 7. Signed voluntary informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Presence of allergic reactions to any of the drugs used 2. Severe cognitive disorders 3. Foraminal and lateral location of spinal canal stenosis and severe narrowing on MRI 4. Distal polyneuropathy of the peroneal and tibial nerves according to electroneuromyography 5. Ankylosing spondylitis 6. Rheumatoid diseases 7. Atherosclerotic peripheral arterial disease of the lower extremities 8. Muscular dystrophies of the lower extremities 9. Motor deficit 10. Bladder and bowel dysfunction 11. Diabetes mellitus 12. Pregnancy 13. Undergoing physiotherapy or acupuncture treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Before treatment, a week after treatment, after 2 months and 4 months of observation: 1. Pain assessment by visual analogue scale and McGill Pain questionnaire 2. Assessment of impaired sensation: temperature, tactile and vibratory sensation by 5-point scale 3. Assessment of neurogenic claudication by Zurich Claudication Questionnaire (ZCQ) 4. Step activity monitoring by a pedometer 5. Motor deficit by 5-point scale 6. Electroneuromyography (ENMG): 6.1. Amplitude of Compound Muscle Action Potential (CMAP): 6.2. Terminal Latency 6.3. Conduction Velocity 6.4. Amplitude of Evoked Potential of Sural Nerves 6.5. F-wave and A-wave Abnormalities 7. MRI will measure the narrowing of the spinal canal at the L4-S1 level before and after decompression surgery and at the end of the follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Before treatment, a week after treatment, after 2 months and 4 months of observation: 1. Quality of life by SF-36 questionnaire 2. Quality of enjoyment by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) 3. Assessment of sexuality disorders by the Sexual Function Evaluation Questionnaire (SFEQ) | — |
Countries
Russian Federation