NCT06078163

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

September 28, 2023

Last Update Submit

October 5, 2023

Conditions

Sciatic Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

Treatment Group

EXPERIMENTAL

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: supplementationOther: rehabilitation

Control Group

PLACEBO COMPARATOR

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

Other: rehabilitation

Interventions

supplementationOTHER

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 Group
rehabilitationOTHER

rehabilitation protocol lasting 20 sessions.

Control GroupTreatment Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Altered states of consciousness;
  • Sciatica not of disc origin
  • Neurological disorders
  • Presence of scoliosis \>20° of Cobb
  • Previous spinal surgery
  • Pregnancy and/or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Palermo, 90127, Italy

Location

MeSH Terms

Interventions

Dietary SupplementsRehabilitation

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 11, 2023

Study Start

July 1, 2022

Primary Completion

March 4, 2023

Study Completion

August 22, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)