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

NCT ID: NCT06078163

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-08-22

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?

Detailed Description

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Conditions

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Sciatic Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

supplementation

Intervention Type 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

rehabilitation

Intervention Type OTHER

rehabilitation protocol lasting 20 sessions.

Control Group

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

Group Type PLACEBO_COMPARATOR

rehabilitation

Intervention Type OTHER

rehabilitation protocol lasting 20 sessions.

Interventions

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supplementation

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

rehabilitation

rehabilitation protocol lasting 20 sessions.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Palermo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MFR0042023

Identifier Type: -

Identifier Source: org_study_id

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