Entrapment Neuropathy, Carpal TunnelPhase 4NCT01895621
Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
A Phase 4 study testing Median nerve decompression at the wrist and Alpha lipoic acid post median nerve decompression in people with Entrapment Neuropathy, Carpal Tunnel and Compression Neuropathy, Carpal Tunnel, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Entrapment Neuropathy, Carpal Tunnel, Compression Neuropathy, Carpal Tunnel, Median Neuropathy, Carpal Tunnel
- What is being tested?
- Median nerve decompression at the wrist and Alpha lipoic acid post median nerve decompression
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Jun 2015
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from primary carpal tunnel syndrome, confirmed clinically and with nerve conduction studies
Who cannot join
- Recurrent or secondary carpal tunnel syndromes.
- Diabetic patients.
- Patients with pace-makers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.
The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.
Read more
Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization, patients will be placed into one of two groups:
Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.
Group B: surgical decompression of the median nerve followed by treatment with placebo
The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.
Read the detailed description
The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function, often also because of a prolonged illness prior to the decompression, causing extensive damage to the nerve, including demyelination, or other morphofunctional deficits. For this reason it could be particularly useful to associate a dietary supplement as a support to the structure and physiology of nerve in the post-decompression period. In this respect, the alpha-lipoic acid molecule seems to be a particularly interesting. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.
The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.
Patients will be enrolled with proven carpal tunnel syndrome, confirmed by a careful examination including the diagnostic maneuvers Phalen, Tinel and antiPhalen. By means of randomization, patients will be placed into one of two groups:
Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.
Group B: surgical decompression of the median nerve followed by treatment with placebo Surgical treatment is performed in both groups according to the standard for this type of intervention, and within 90 days after joining the waiting list.
Patients will be excluded in case of recurrent carpal tunnel syndrome. Other causes of exclusion will be carpal tunnel syndrome associated with diabetes mellitus or rheumatoid hand or secondary to other causes, uncooperative patients with poor compliance with treatment, patients with hypersensitivity to the product or one of its components, patients with pace-maker as this does not allow nerve conduction studies and electromyography, needed to evaluate pre and post treatment.
The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.
Secondary endpoints:
- assessment of pain reported by the patient using the VAS (Visual Analogue Scale).
- Clinical evaluation objective (presence of paresthesia and two-point discrimination on the tip of the index finger, and subjective (symptom description by the patient by means of tests and Levine-Katz questionnaire) at 3 and 6 months.
- Conditions
- Entrapment Neuropathy, Carpal Tunnel, Compression Neuropathy, Carpal Tunnel, Median Neuropathy, Carpal Tunnel
- Being tested
- Median nerve decompression at the wrist, Alpha lipoic acid post median nerve decompression
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Median nerve decompression at the wristProcedure or surgery
Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.
Alpha lipoic acid post median nerve decompressionDietary supplement
Daily supplementation of alpha lipoic acid
| Study group | Role | What they receive |
|---|---|---|
| Lipoic | Experimental | Median nerve decompression at the wrist, followed by Alpha lipoic acid post median nerve decompression: lipoic acid, 800 mg daily for 40 days from the day of the operation, tablets. Receives: Procedure: Median nerve decompression at the wrist; Dietary Supplement: Alpha lipoic acid post median nerve decompression |
| placebo | Placebo comparator | Median nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid Receives: Procedure: Median nerve decompression at the wrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Median nerve conduction velocity
Measured: Preoperatively and 90 days after median nerve decompression
Secondary outcomes (2)
Score with Boston questionnaire on carpal tunnel syndrome
Measured: Preoperatively and 90 days postdecompression
Two point discrimination test on index finger pulp
Measured: Preoperatively and 90 days postdecompression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Entrapment Neuropathy, Carpal TunnelStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filippo Boriani, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895621
- Sponsor's protocol ID
- TUNNEL ALFALIPO
- Status last verified
- Jan 2015
- First submitted
- 25 Jun 2013
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01895621
- Acronym / sponsor ID
- TUNNEL ALFALIPO
- Conditions
- Entrapment Neuropathy, Carpal Tunnel, Compression Neuropathy, Carpal Tunnel, Median Neuropathy, Carpal Tunnel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- 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 postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.
The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.
Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization, patients will be placed into one of two groups:
Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.
Group B: surgical decompression of the median nerve followed by treatment with placebo
The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.
Detailed description
The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function, often also because of a prolonged illness prior to the decompression, causing extensive damage to the nerve, including demyelination, or other morphofunctional deficits. For this reason it could be particularly useful to associate a dietary supplement as a support to the structure and physiology of nerve in the post-decompression period. In this respect, the alpha-lipoic acid molecule seems to be a particularly interesting. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.
The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.
Patients will be enrolled with proven carpal tunnel syndrome, confirmed by a careful examination including the diagnostic maneuvers Phalen, Tinel and antiPhalen. By means of randomization, patients will be placed into one of two groups:
Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.
Group B: surgical decompression of the median nerve followed by treatment with placebo Surgical treatment is performed in both groups according to the standard for this type of intervention, and within 90 days after joining the waiting list.
Patients will be excluded in case of recurrent carpal tunnel syndrome. Other causes of exclusion will be carpal tunnel syndrome associated with diabetes mellitus or rheumatoid hand or secondary to other causes, uncooperative patients with poor compliance with treatment, patients with hypersensitivity to the product or one of its components, patients with pace-maker as this does not allow nerve conduction studies and electromyography, needed to evaluate pre and post treatment.
The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.
Secondary endpoints:
- assessment of pain reported by the patient using the VAS (Visual Analogue Scale).
- Clinical evaluation objective (presence of paresthesia and two-point discrimination on the tip of the index finger, and subjective (symptom description by the patient by means of tests and Levine-Katz questionnaire) at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipoic | Experimental | Procedure: Median nerve decompression at the wrist, Dietary Supplement: Alpha lipoic acid post median nerve decompressionMedian nerve decompression at the wrist, followed by Alpha lipoic acid post median nerve decompression: lipoic acid, 800 mg daily for 40 days from the day of the operation, tablets. |
| placebo | Placebo comparator | Procedure: Median nerve decompression at the wristMedian nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from primary carpal tunnel syndrome, confirmed clinically and with nerve conduction studies
Key exclusion criteria (3 listed)
- Recurrent or secondary carpal tunnel syndromes.
- Diabetic patients.
- Patients with pace-makers.
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 |
|---|---|---|
| Median nerve decompression at the wristSurgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve. | Procedure or surgery | Lipoic, placebo |
| Alpha lipoic acid post median nerve decompressionDaily supplementation of alpha lipoic acid | Dietary supplement | Lipoic |
Primary outcome
Change in Median nerve conduction velocity
Time frame: Preoperatively and 90 days after median nerve decompression
2 secondary outcomes
Score with Boston questionnaire on carpal tunnel syndrome
Time frame: Preoperatively and 90 days postdecompression
Two point discrimination test on index finger pulp
Time frame: Preoperatively and 90 days postdecompression
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 24 Jun 2015.
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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.
Filippo Boriani, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Median nerve decompression at the wrist and Alpha lipoic acid post median nerve decompression in people with Entrapment Neuropathy, Carpal Tunnel and Compression Neuropathy, Carpal Tunnel, run by Istituto Ortopedico Rizzoli 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 1 inclusion and 3 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 24 Jun 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Median nerve conduction velocity (time frame: Preoperatively and 90 days after median nerve decompression). 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 24 Jun 2015.