The patients were randomized to receive oral combination of alpha lipoic acid and vitamin
B (alpha lipoic acid; 300mg, methylcobalamin; 500mcg, vitamin B1; 39mg and vitamin B6;
8mg), 2 tablets once daily or placebo drug (maltodextrin, microcrystalline cellulose,
tricalcium phosphate, silicon gioxide, magnesium stearate) 2 tablets once daily.
Randomization sequence was done by using an online random number generator program using
a mixed block randomization technique at a ratio of 1:1. In cases of serious adverse
event, unblinding process was incorporated where the identity of the drug was revealed to
manage the subject's condition. This was done by intruding the emergency code key by the
researcher. All patients provided a written consent for the study.
During visit 1, a thorough history and physical examination were done, and demographic
data was collected. Afterward, the patients were required to answer three sets of
self-administered questionnaires: Boston Carpal Tunnel Questionnaire (BCTQ), Visual
analogue score (VAS) and SF-36. The BCTQ is a specific questionnaire for assessing CTS
that consists of two distinct scales, the Symptom Specific Scale (SSS) which has 11 items
and the Functional Status Scale (FSS) containing 8 items. Each scale generates a final
score ranging from 1 to 5, with a higher score indicating greater disability and poor
symptoms control. BCTQ is a reliable questionnaire to assess CTS owing to its high
cross-cultural adaptation and multilingual validity and reliability. The VAS is a visual
scale with 0 scored as "no pain" and 10 as "worst pain imaginable" and serves as an
excellent tool for pain score with excellent validity and reproducibility. The SF-36 is a
quality-of-life questionnaire that comprises of 36 questions covering eight domains of
health which are; Physical Functioning (PF), Role Limitations due to Physical Health,
Role Limitations (RL) due to Emotional Problems (RE), energy/fatigue, emotional
well-being, social functioning, pain, and general health (GH) where a higher score
indicates a better outcome . After the administration of these questionnaires, they will
be subjected for a nerve conduction study (NCS) to determine the severity of CTS. The NCS
were performed by the same trained personnel to ensure consistency and accuracy.
The patients were reassessed at Visit 2 (3 months post-treatment) and Visit 3 (6 months
post-treatment). During each visit, they underwent physical examination, NCS, and were
required to complete the three sets of questionnaires (BCTQ, VAS, and SF-36). They were
also required to fill in the form regarding the side effects of the treatments. The
investigators made a phone call and sent reminder message at the 6th and 18th week to
ensure compliance, medication adequacy and follow up review. During the study, patients
were allowed to undergo the standard of care treatment at our center such as
physiotherapy.
