Sciatic RadiculopathyNCT06078163
Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
A study testing supplementation and rehabilitation in people with Sciatic Radiculopathy, run by University of Palermo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sciatic Radiculopathy
- What is being tested?
- supplementation and rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 22 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Palermo, 90127
About this study
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?
- Conditions
- Sciatic Radiculopathy
- Being tested
- supplementation, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
rehabilitationOther
rehabilitation protocol lasting 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: supplementation; Other: rehabilitation |
| Control Group | Placebo comparator | Control Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions. Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
extent of pain.
Numeric Rating Scale (0-10)
Measured: 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
Oswestry Disability Questionnaire (ODQ) (0-50)
Measured: 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
36-item Short Form Health Survey (SF-36) (0-100)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jul 2022
- Primary completion4 Mar 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078163
- Sponsor's protocol ID
- MFR0042023
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
- ClinicalTrials.gov ID
- NCT06078163
- Acronym / sponsor ID
- MFR0042023
- Conditions
- Sciatic Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: supplementation, Other: rehabilitationTreatment 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 | Placebo comparator | Other: rehabilitationControl Group was composed of patients who will only undergo a rehabilitation protocol lasting 20 sessions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Altered states of consciousness;
- Sciatica not of disc origin
- Neurological disorders
- Presence of scoliosis >20° of Cobb
- Previous spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementationdaily 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 | Treatment Group |
| rehabilitationrehabilitation protocol lasting 20 sessions. | Other | Control Group, Treatment Group |
Primary outcome
extent of pain.
Time frame: 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)
2 secondary outcomes
degree of disability of low back pain
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation and rehabilitation in people with Sciatic Radiculopathy, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extent of pain. (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.