Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
October 5, 2023 updated by: Prof.ssa Giulia Letizia Mauro, University of Palermo
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Palermo, Italy, 90127
- Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
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
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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
rehabilitation protocol lasting 20 sessions.
|
|
Placebo Comparator: Control Group
Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions.
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rehabilitation protocol lasting 20 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
extent of pain.
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)
|
Numeric Rating Scale (0-10)
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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
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)
|
Oswestry Disability Questionnaire (ODQ) (0-50)
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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
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)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
March 4, 2023
Study Completion (Actual)
August 22, 2023
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
October 5, 2023
First Posted (Actual)
October 11, 2023
Study Record Updates
Last Update Posted (Actual)
October 11, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFR0042023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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