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

U

University of Palermo

Status

Completed

Conditions

Sciatic Radiculopathy

Treatments

Other: rehabilitation
Other: supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT06078163
MFR0042023

Details and patient eligibility

About

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?

Enrollment

130 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

130 participants in 2 patient groups, including a placebo group

Treatment Group
Experimental group
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
Treatment:
Other: supplementation
Other: rehabilitation
Control Group
Placebo Comparator group
Description:
Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions.
Treatment:
Other: rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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