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Multicenter Study
. 2017 Dec;31(12):1103-1111.
doi: 10.1007/s40263-017-0476-2.

L-Acetyl-carnitine in Patients with Carpal Tunnel Syndrome: Effects on Nerve Protection, Hand Function and Pain

Giorgio Cruccu  1 , G Di Stefano  2 , F Fattapposta  3 , S Jann  4 , L Padua  5   6 , A Schenone  7 , A Truini  2
Affiliations
Multicenter Study

L-Acetyl-carnitine in Patients with Carpal Tunnel Syndrome: Effects on Nerve Protection, Hand Function and Pain

Giorgio Cruccu et al. CNS Drugs. 2017 Dec.

Erratum in

Abstract

Background and aim: L-Acetyl-carnitine (LAC) exerts an energetic effect on nerves and muscles. Recently, preclinical experiments have demonstrated a central anti-nociceptive action.

Objective: Our objective was to assess the effects of LAC on neuroprotection, pain, and function in carpal tunnel syndrome (CTS), a very frequent chronic compressive neuropathy.

Methods: In a multicentre, examiner-blinded, clinical and neurophysiological 4-month study, we enrolled 82 patients and examined 120 hands with CTS of mild to moderate severity. Patients were assessed at baseline and 10, 60 and 120 days after treatment with LAC 500 mg twice daily (BID). All patients underwent a conduction study of the median nerve, the Boston Carpal Tunnel Questionnaire (BCTQ) and the Neuropathic Pain Symptom Inventory (NPSI). The primary endpoint was the sensory conduction velocity (SCV) of the median nerve.

Results: The primary endpoint was met, with significant improvement of the SCV (P < 0.0001). All sensory neurophysiological measures also significantly improved. BCTQ score changed significantly (P < 0.0001), with a greater improvement in the symptom component. Nine of the NPSI types of pain, particularly squeezing and pressure pain and pain evoked by pressure, showed a significant reduction (P < 0.0001).

Conclusions: Our clinical and neurophysiological study indicated that 4 months of treatment with LAC exerted a neuroprotective effect. LAC reduced pain in patients with mild and moderate CTS, a result that is possibly due to both its neuroprotective action and its central anti-nociceptive properties. Clinical Trials Registration code: EudraCT 2014-002289-62.

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Conflict of interest statement

Funding

The trial was funded by Sigma-Tau of ALFASIGMA Group. Open access was funded by Sigma-Tau of ALFASIGMA Group.

Conflict of interest

Giorgio Cruccu has received a research grant, consulting fees and payments for lectures from Sigma-Tau of ALFASIGMA Group, and consulting fees from Angelini, Biogen, and Mundipharma. Giulia Di Stefano, Francesco Fattapposta, and Luca Padua have no conflicts to declare. Stefano Jann has received payments for lectures and consulting fees from Sigma-Tau of ALFASIGMA Group and Gruenenthal and a research grant from Grifols. Angelo Schenone has received payments for lectures from Sigma-Tau of ALFASIGMA Group, Mundipharma, Ecupharma, Kedrion, CSL Behering, and Epitech. Andrea Truini has received payments for lectures from Sigma-Tau of ALFASIGMA Group and consulting fees or payment for lectures from Angelini, Gruenenthal and Pfizer.

Ethics approval

The study protocol, patient information and informed consent forms were reviewed and approved by the Institutional Review Board at the participant hospitals.

Consent to participate

All participants provided written informed consent before taking part in study procedures. All procedures were in accordance with Good Clinical Practice and the principles of the Declaration of Helsinki.

Figures

Fig. 1
Fig. 1
Flow-chart of participants and study design. BID twice daily, ITT intention to treat, NCS nerve conduction study, t0, t10, t60, and t120 indicate the day of visit
Fig. 2
Fig. 2
Results of the median-nerve conduction study in 82 patients. ANOVA analysis of variance, CMAP compound motor action potential, SAP amplitude of the sensory action potentials, SCV sensory conduction velocity. Squares are mean ± standard error. P ANOVA for repeated measures. Note that all sensory measures improve significantly and linearly, whereas the changes in amplitude of motor potentials are not significant
Fig. 3
Fig. 3
Boston Carpal Tunnel Questionnaire (BCTQ). Squares are mean ± 95% confidence intervals. P Friedman test. Note that the effect size, although statistically significant for both BCTQ parts, is greater for the symptom than for the functional part
See this image and copyright information in PMC

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