Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People

Study Overview
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Brief Summary
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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?

Official Title
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Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People

Conditions
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Sciatic Radiculopathy

Intervention / Treatment
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* Other: supplementation
* Other: rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Treatment Group was composed of patients who will undergo 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 | Other: supplementation<br>* 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<br>Other: rehabilitation<br>* rehabilitation protocol lasting 20 sessions.<br>|
| Placebo Comparator: Control Group<br>Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions. | Other: rehabilitation<br>* rehabilitation protocol lasting 20 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extent of pain. | Numeric Rating Scale (0-10) | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of disability of low back pain | Oswestry Disability Questionnaire (ODQ) (0-50) | 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) | 
| quality of life in relation to low back pain | 36-item Short Form Health Survey (SF-36) (0-100) | 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) |