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

Not Applicable

Completed

• Conditions: Sciatic Radiculopathy
• Interventions: Other: supplementation; Other: rehabilitation

• Registration Number: NCT06078163
• Lead Sponsor: University of Palermo

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-03-04
• Study Completion: 2023-08-22
• Study First Submitted: 2023-09-28
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-05
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone; 🇮🇹 Palermo, Italy