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

Sciatic Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06078163
• Other study ID #: MFR0042023
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 22, 2023

Study information

• Verified date: October 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 22, 2023
• Est. primary completion date: March 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiculopathy
• Sciatic Radiculopathy
• Sciatica

Intervention

Other:
• 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
• rehabilitation
rehabilitation protocol lasting 20 sessions.

Locations

Country	Name	City	State
Italy	Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extent of pain.	Numeric Rating Scale (0-10)	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	degree of disability of low back pain	Oswestry Disability Questionnaire (ODQ) (0-50)	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	quality of life in relation to low back pain	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)