Acetyl-L-carnitine (ALCAR) to enhance nerve regeneration in carpal tunnel syndrome: study protocol for a randomized, placebo-controlled trial

What Was Tested

Researchers studied L-Carnitine in the context of carpal tunnel in this randomized controlled trial publication.

The researchers aim to recruit ten patients into each of the two groups.

Why It Was Studied

Acetyl-L-carnitine (ALCAR) is involved in lipid transport, vital for mitochondrial function.

NCT02141035 ; 20 April 2015.

Who Took Part

Inclusion criteria will include adult patients with severe CTS.

The primary outcome will be MUNE with supplementary secondary outcome measures that include: 1) two-point discrimination; 2) Semmes-Weinstein monofilaments for pressure sensitivity; 3) cold and pain threshold for small fiber function; 4) Boston self-assessment Carpal Tunnel Questionnaire and 5) Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire for symptom severity; and 6) Purdue Pegboard Test for hand functional performance.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and pilot study.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with L-Carnitine could be set against what happens without it.

It is described as a pilot, a small early test of whether a larger L-Carnitine study would be practical.

In this pilot study the researchers will utilize a double-blind, randomized, placebo-controlled design.

This will be confirmed by nerve conduction studies and motor unit number estimation (MUNE).

Only those with severe motor unit loss in the thenar muscles (2 standard deviations [SD] below the mean for the age group) will be included.

To follow post treatment recovery and monitor safety, patients will be seen at 3 months, 6 months and 1 year.

The outcome measures will be analyzed using two-way ANOVA, with treatment assignment and time points being the independent factors.

What Was Measured

Topics PubMed links to this paper include Acetylcarnitine, Alberta, Carpal Tunnel Syndrome, Clinical Protocols, Combined Modality Therapy, Disability Evaluation and Nerve Regeneration.

Author keywords: Acetyl-L-carnitine, Motor unit number estimation and Peripheral nerve injury.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of L-Carnitine in people with carpal tunnel.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2016 (Trials), a journal based in England.

More context: the L-Carnitine compound page, Carpal tunnel research.