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

Primary Purpose

Sciatic Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
supplementation
rehabilitation
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatic Radiculopathy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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 was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions.

Outcomes

Primary Outcome Measures

extent of pain.
Numeric Rating Scale (0-10)

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2023
Last Updated
October 5, 2023
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT06078163
Brief Title
Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
Official Title
Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
March 4, 2023 (Actual)
Study Completion Date
August 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatic Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions.
Intervention Type
Other
Intervention Name(s)
supplementation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
rehabilitation
Intervention Description
rehabilitation protocol lasting 20 sessions.
Primary Outcome Measure Information:
Title
extent of pain.
Description
Numeric Rating Scale (0-10)
Time Frame
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 Measure Information:
Title
degree of disability of low back pain
Description
Oswestry Disability Questionnaire (ODQ) (0-50)
Time Frame
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)
Title
quality of life in relation to low back pain
Description
36-item Short Form Health Survey (SF-36) (0-100)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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