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OpenTrials
Completed

NCT Number: NCT06078163

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

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?

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Key information

Conditions

Sciatic Radiculopathy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

rehabilitation

Other

rehabilitation protocol lasting 20 sessions.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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