This is a prospective clinical trial run from February to August 2020 on 47 patient within the 30 to 60 age range with paresthesia, dysesthesia, and Tenar muscle weakness who tested positive for Phalen and Tinel test. The tests’ outcomes are confirmed by neurophysiological tests (EMG-NCV) for mild to moderate CTS. Severity of CTS is as follows: normal (grade 0); very mild (grade 1), CTS demonstrable only with most sensitive tests; mild (grade 2), sensory nerve conduction velocity slow on finger/wrist measurement, normal terminal motor latency; moderate (grade 3), sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) < 6.5 ms; severe (grade 4), sensory potentials absent but motor response preserved, distal motor latency to APB < 6. 5 ms; very severe (grade 5), terminal latency to APB > 6.5 ms; extremely severe (grade 6), sensory and motor potentials effectively unrecordable (surface motor potential from APB < 0.2 mV amplitude)(16). The exclusion criteria consist of Diagnosis of sensory and/or motor neuropathy other than CTS, Previous wrist trauma, surgery for CTS, treatment with ultrasound, ESWT, or local corticosteroid injection, pregnancy, infection at the treatment site, Scar burn, and systemic diseases (Rheumatoid arthritis-lupus erythema-scleroderma). The study protocol is subject to the Institutional Review Board and the Ethics Committee of Shahid Beheshti University of Medical Sciences regulations, which are explained to the participants[IR.SBMU.RETECH.REC.1399.1150]. Applying night splints and other oral medications is prohibited during the course, and all patients sign an informed consent. The subjects are labeled and randomly assigned through a random assignment sequence generated by the software to group 1 (sham -ESWT) and group 2(ESWT). The triamcinolone acetone (1 ml) + lidocaine (1ml) is injected into all the areas between the palmaris longus tendon (PL) and the flexor carpi ulnaris tendon (FCU) in the wrist area once(17). Local corticosteroid is injected 24 hours later to prevent skin sensitivity after the ESWT.
Each patient is subjected to the ESWT (electromagnetic standard DUOLITH SD1, Storz Medical, Tägerwilen, Switzerland) device. In the second group, ESWT is performed in the first session at 2600 beats average (with focusing probe) and a very low, 0.03 mj / mm2 energy flux density. Depending on patient tolerance, this energy follows a gradual incremental pattern for the next three sessions. The pulse repetition frequency is 4 Hz. In the (sham-ESWT) group, the ESWT device waves less and generates sound. At this stage, the patient is seated with the arm on the table and the palm facing up, and the ESWT probe is held vertically to the zone between the tenar and hypothenar ridges. All participants underwent clinical follow-up before beginning the treatment, at the end of the 1st, 3rd, and 6th months for VAS scores, and filled out the GSS questionnaire. This questionnaire covers the pain, numbness, paresthesia, weakness/clumsiness, and nocturnal waking (18). The Scale of GSS begins from 0 (no symptoms) to 10 (very severe), with the 50 as the worst score. The pain severity is measured through the Visual Analog Scale (VAS) (19), where 0 and 10 indicate no pain and the most severe imaginable pain, respectively. All treatments are run by a team of one orthopedic and one physiotherapist. At the end of the 6th month, patients with exacerbation of paresthesia, finger tingling, and decreased strength symptoms are referred for surgery after being confirmed by the EMG-NCV. The statistical analyses are run in SPSS software (SPSS, Inc., Chicago, IL, USA, Version 16) with a significance level of 5% and a 95% confidence interval. Descriptive data are reported as the mean ± SD. A Chi-square test is run for qualitative variables, and a student’s t-test is run to compare pain and Global symptom scores between the subject groups. Repeated measurements of ANOVA is applied to compare the Visual Analog Scale score and Global Symptom score trends within and between the groups.