Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome

What Was Tested

This registered phase 2, phase 3 trial tested L-Carnitine for carpal tunnel.

In severe cases, nerve regeneration and functional recovery are incomplete even with surgery.

It had two arms (groups): Acetyl-l-carnitine (experimental) and Placebo (placebo comparator).

Placebo will be given for 2 months starting at the time of decompression surgery.

The registry classes the interventions as drug.

More on the Plan

The study will be carried out according to Good Clinical Practice standards.

No deviation from the protocol will occur once approved, unless the protocol has put patients at risk.

If deviation needs to occur, both HREB and Health Canada will be notified.

Written amendments will be submitted to both HREB and Health Canada for their approval.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Numbness and parenthesis in the median nerve distribution;. Precipitation of those symptoms by repetitive motions that are relieved by rubbing and or shaking the hands;. Nocturnal awakening by those sensory symptoms, or. Weakness of thumb abduction and thenar atrophy.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: motor unit loss in the median nerve less than 2 sd below the mean for the age as determined by nerve conduction studies; the presence of other neurologic conditions; previous carpal tunnel release surgery.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the carpal tunnel participants stayed in one arm throughout.

Blinding on both sides kept the carpal tunnel participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-09 with completion listed for 2017-06.

It ran at 3 sites in Canada (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in motor unit number estimates (time frame: Baseline, 3, 6, and 12 months).

It also tracked 7 secondary outcomes, for example Change in two point discrimination, Change in pressure sensitivity using Semmes-Weinstein Monofilaments, Change in cold detection threshold, Change in pain detection thresholds, Change in hand dexterity using the Purdue Pegboard and Change in disability scores using the Disability of Arm, Shoulder and Hand questionnaire.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of L-Carnitine in 20 people with carpal tunnel.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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