Carpal Tunnel SyndromePhase 2NCT02382328
Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Carpal Tunnel Syndrome Undergoing Surgical Release
A Phase 2 study testing alpha lipoic acid in people with Carpal Tunnel Syndrome, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- alpha lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2016to Jul 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical and electrophysiological diagnosis of carpal tunnel syndrome
Who cannot join
- rheumatic diseases
- distal radio or carpal fractures.
- pregnant women
- alpha lipoid acid allergy
- local injections (ej. steroid carpal injections)
- peripheral nervous system diseases (which may cause nerve conduction study abnormalities).
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Effectiveness of Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Patients With Carpal Tunnel Syndrome Surgical Release
The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.
Read the detailed description
The main purpose of this study is to determine the effectiveness of using an oral supplementation of alpha lipoid acid to improve clinical and electrophysiological recovery after carpal tunnel release surgery. This research is designed as a double blinded clinical trial, with a calculated sample size of 40 patients, divided in two groups of 20 (A placebo, B alpha lipoid acid). All patients will undergo open carpal tunnel release surgery, the procedure will be performed by an expert surgeon. A total of four visits will be performed as follows: T0. baseline 4 weeks before surgery, T1 immediately before surgery, T2: 4 weeks after surgery, T3: 8 weeks after surgery, T4: 12 weeks after surgery. The assessment to be perform on each visit includes: physical examination, Boston Questionary for Carpal Tunnel Syndrome. Nerve conduction study and ecographic evaluation will be performed on visits T0, T1 and T4. Statistical Analysis: Categorical variables will be assessed as counts and percent frequency and compared using the chi-squared test. All statistical analyses will be performed using the SPSS 21.0 package (SPSS Inc., Chicago, IL, USA). A two-tailed P value < 0.05 was considered statistically significant.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- alpha lipoic acid, Placebo
- 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.
alpha lipoic acidDrug
Also called thiocitic acid
comparison of 600mg/24h oral, alpha lipoid acid, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
PlaceboDrug
Also called inactive magnesium
Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
| Study group | Role | What they receive |
|---|---|---|
| alpha lipoic acid | Experimental | 600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release. Receives: Drug: alpha lipoic acid |
| Placebo | Placebo comparator | Oral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)
using nerve conduction studies to determine median sensory latency.
Measured: 120 days after surgery
Secondary outcomes (1)
cross sectional area of median nerve (sonographic measurement to determine cross sectional area of median nerve.)
sonographic measurement to determine cross sectional area of median nerve.
Measured: 120 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Alejandra Monroy Guizar, Hospital Civil de Guadalajara
- Investigators
- Leonel Garcia, PhD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382328
- Sponsor's protocol ID
- 265/14
- Status last verified
- Aug 2016
- First submitted
- 18 Feb 2015
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Pajardi G, Bortot P, Ponti V, Novelli C. Clinical usefulness of oral supplementation with alpha-lipoic Acid, curcumin phytosome, and B-group vitamins in patients with carpal tunnel syndrome undergoing surgical treatment. Evid Based Complement Alternat Med. 2014;2014:891310. doi: 10.1155/2014/891310. Epub 2014 Jan 19.
PubMed 24563654Di Geronimo G, Caccese AF, Caruso L, Soldati A, Passaretti U. Treatment of carpal tunnel syndrome with alpha-lipoic acid. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):133-9.
PubMed 19499849
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Patients With Carpal Tunnel Syndrome Surgical Release
- ClinicalTrials.gov ID
- NCT02382328
- Acronym / sponsor ID
- 265/14
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Mar 2015 (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 main purpose of this study is to determine the effectiveness of use Alpha lipoic acid before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.
Detailed description
The main purpose of this study is to determine the effectiveness of using an oral supplementation of alpha lipoid acid to improve clinical and electrophysiological recovery after carpal tunnel release surgery. This research is designed as a double blinded clinical trial, with a calculated sample size of 40 patients, divided in two groups of 20 (A placebo, B alpha lipoid acid). All patients will undergo open carpal tunnel release surgery, the procedure will be performed by an expert surgeon. A total of four visits will be performed as follows: T0. baseline 4 weeks before surgery, T1 immediately before surgery, T2: 4 weeks after surgery, T3: 8 weeks after surgery, T4: 12 weeks after surgery. The assessment to be perform on each visit includes: physical examination, Boston Questionary for Carpal Tunnel Syndrome. Nerve conduction study and ecographic evaluation will be performed on visits T0, T1 and T4. Statistical Analysis: Categorical variables will be assessed as counts and percent frequency and compared using the chi-squared test. All statistical analyses will be performed using the SPSS 21.0 package (SPSS Inc., Chicago, IL, USA). A two-tailed P value < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha lipoic acid | Experimental | Drug: alpha lipoic acid600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release. |
| Placebo | Placebo comparator | Drug: PlaceboOral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical and electrophysiological diagnosis of carpal tunnel syndrome
Key exclusion criteria (6 listed)
- rheumatic diseases
- distal radio or carpal fractures.
- pregnant women
- alpha lipoid acid allergy
- local injections (ej. steroid carpal injections)
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 |
|---|---|---|
| alpha lipoic acidAlso: thiocitic acidcomparison of 600mg/24h oral, alpha lipoid acid, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients. | Drug | alpha lipoic acid |
| PlaceboAlso: inactive magnesiumPlacebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients. | Drug | Placebo |
Primary outcome
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)
Time frame: 120 days after surgery
using nerve conduction studies to determine median sensory latency.
1 secondary outcome
cross sectional area of median nerve (sonographic measurement to determine cross sectional area of median nerve.)
Time frame: 120 days after surgery
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 9 Aug 2016.
- Results publication: PubMed 24563654Pajardi G, Bortot P, Ponti V, Novelli C. Clinical usefulness of oral supplementation with alpha-lipoic Acid, curcumin phytosome, and B-group vitamins in patients with carpal tunnel syndrome undergoing surgical treatment. Evid Based Complement Alternat Med. 2014;2014:891310. doi: 10.1155/2014/891310. Epub 2014 Jan 19.
- Results publication: PubMed 19499849Di Geronimo G, Caccese AF, Caruso L, Soldati A, Passaretti U. Treatment of carpal tunnel syndrome with alpha-lipoic acid. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):133-9.
- Individual participant dataSharing planned: Yes
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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.
Leonel Garcia, PhD study director
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alpha lipoic acid in people with Carpal Tunnel Syndrome, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 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 9 Aug 2016. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.) (time frame: 120 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382328, which also lists 2 linked publications.
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 9 Aug 2016.