Sciatic Radiculopathy
Conditions
Brief summary
The objective of this Interventional case-control clinical study is to evaluate the effectiveness of physiotherapy combined with the administration of Alpha Lipoic Acid, L-acetylcarnitine, Resvelatrol, Vit D3 in the treatment of sciatica due to herniated disc in young patients. The main questions we intend to answer are: * Is this combined treatment more effective in reducing pain? * Is the combined treatment useful for improving postural alterations, reducing the intake of painkillers and the number of days of absence from work and improving the quality of life?
Interventions
OTHERsupplementation
daily pharmacological therapy with Alpha Lipoic Acid 600 mg, L-acetylcarnitine 1000 mg, Resvelatrol 50 mg, vit D3 800UI for 30 consecutive days in combination with a rehabilitation protocol lasting 20 sessions
OTHERrehabilitation
rehabilitation protocol lasting 20 sessions.
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-45 years * pain with NRS scale score between 5 and 7 points * symptoms attributable to lumbosciatica which occurred no more than 4 weeks ago * pharmacological wash out of NSAIDs and corticosteroids for at least a week * presence of L4-L5, L5-S1 disc herniation diagnosed with lumbar MRI performed within 3 months * absence of ongoing infectious episodes; * written consent for participation in the study.
Exclusion criteria
* Altered states of consciousness; * Sciatica not of disc origin * Neurological disorders * Presence of scoliosis \>20° of Cobb * Previous spinal surgery * Pregnancy and/or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| extent of pain. | at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2) | Numeric Rating Scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| degree of disability of low back pain | at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2) | Oswestry Disability Questionnaire (ODQ) (0-50) |
| quality of life in relation to low back pain | at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2) | 36-item Short Form Health Survey (SF-36) (0-100) |
Countries
Italy
Outcome results
None listed