Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Clinical Trial
Phase: NA
Conditions: Carpal Tunnel Syndrome
Sponsor: Hospital Universitario Reina Sofia de Cordoba

COMPARISON OF TWO TECHNIQUES FOR THE TREATMENT OF 
CARPAL TUNNEL SYNDROME. RANDOMIZED CLINICAL TRIAL 
 
ID: NCT05468814 
Date: November 3, 2023 
 
January 27, 2022

STUDY PROTOCOL 
Objectives 
To determine if the incidence of postoperative pillar pain is lower for either of the two 
surgical techniques being studied after 3 weeks and 6 months of follow-up 
Secondary, to check if the post-surgical grip strength, pinch strength and Borton Carpal 
Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques  
 
Design 
Randomised clinical trial. 
 
Methods 
Study variables 
• Signs of compression of the median nerve: pain and paresthesias in the first three 
fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle 
atrophy, loss of opposition of the thumb. Durkan, Phalen, Tinel signs. 
• Pillar pain: pain/sensation of allodynia in the area of the thenar and/or hypothenar 
eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, 
dysesthesia at rest. 
• Questionnaire: BCTQ (Boston Carpal Tunnel Syndrome Questionnaire). 
• Grip strength and pinch strength with specific dynamometers 
 
Inclusion criteria 
1) Age > 18 years 
2) Moderate-severe carpal tunnel syndrome 
3) Symptoms that hinder the patient's daily activities 
4) Have performed a correct conservative treatment without success 
 
Exclusion criteria 
1) Previous carpal tunnel syndrome surgery 
2) Traumatic or congenital sequelae of the hand 
3) Unable to understand the process and the tests to be performed 
 
Design 
The follow-up process was carried out in three visits (3 weeks and 6 months after 
surgery). 
In the pre-surgery visit, we carried out: patient screening and recruitment, patient 
information and obtaining informed consent process, application of the inclusion and 
exclusion criteria, medical history and physical examination of the hand to reach the 
clinical and exploratory diagnosis of carpal tunnel syndrome, obtaining baseline 
values from the BCTQ questionnaire, obtaining baseline grip and pinch strength 
values. After that, patients were randomly assigned to one of two treatment groups. Once 
included in each study group, the specific surgical operation was carried out. Finally, in 
the post-surgery visits (3 weeks and 6 months post-surgery), we evaluated: clinical and 

examination of the median nerve compression clinic, presence or not of pillar pain, post-
operative BCTQ values and grip and pinch strengths. 
 

STATISTICAL ANALYSIS PLAN (SAP) 
To carry out the sample homogeneity study, the statistical Student t-tests for the 
quantitative variables and chi-square for the qualitative variables were used. For the 
analysis of the qualitative variables the chi-square statistical test was used. Mixed 
ANOVA was used using the patient as a random effect and using the visit and surgical 
technique as a fixed effect to analyse the absolute change in grip and pinch strength and 
the BCTQ score after 3 weeks and 6 months after surgery. 
As for the data analysis, two new variables were created for the quantitative variables: 
the absolute change in grip strength, in pinch strength and in the BCTQ score and the 
relative change therein, performed by an absolute and percentage calculation 
(respectively) of the difference between values after 3 weeks from baseline and values 
after 6 months from baseline; i.e., comparing each patient with themself calculating the 
variation in these variables throughout the follow-up. 
Finally, the Student's t-test was used to study the absolute and relative change in the grip 
and pinch strength and BCTQ values.