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

• Sponsor: University of Palermo (Other)
• Overall Status: Completed
• CT.gov ID: NCT06078163
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Sciatic Radiculopathy	Other: supplementation; Other: rehabilitation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Mar 4, 2023
• Actual Study Completion Date: Aug 22, 2023

Arms and Interventions

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	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; Other: rehabilitation; 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.	Other: rehabilitation; rehabilitation protocol lasting 20 sessions.

Outcome Measures

Primary Outcome Measures

1. extent of pain. [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 Outcome Measures

1. degree of disability of low back pain [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 [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone	Palermo		Italy	90127

Sponsors and Collaborators

• University of Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof.ssa Giulia Letizia Mauro, Professor, University of Palermo
• ClinicalTrials.gov Identifier: NCT06078163
• Other Study ID Numbers: MFR0042023
• First Posted: Oct 11, 2023
• Last Update Posted: Oct 11, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Radiculopathy; Sciatica

Study Results

No Results Posted as of Oct 11, 2023