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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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 |
|
| Control Group | Placebo Comparator | Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supplementation | Other | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone | Palermo | 90127 | Italy |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| rehabilitation | Other | rehabilitation protocol lasting 20 sessions. |
|
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) |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |