Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main objective of this study is to compare the complete section of the transverse carpal
      ligament with another median nerve release technique and to determine if the incidence of
      post-surgical pillar pain is lower for either of the two surgical techniques. As secondary
      objectives, we also seek to determine if the postsurgical grip and pincer strength and the
      Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical
      techniques.
    

Detailed description: 
      It will be a randomized clinical trial with a sample size of about 80 patients. It will have
      two study groups: the experimental group (in which 40 patients will be included) where a
      Z-plasty technique will be applied; and the control group (another 40 patients) who will
      undergo the conventional technique of complete section of the transverse carpal ligament. The
      main variable will be the presence or absence of post-surgical pillar pain and, as secondary
      variables, the recovery of grip and pincer strength and the improvement in the BCTQ score
      will be studied.

      The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain
      and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal
      paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs ,
      Phalen and Tinnel positive) and with a positive electromyogram test classified as "moderate"
      or "severe". As inclusion criteria, patients >18 years of age with moderate-severe carpal
      tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed
      conservative treatment will be considered. Those who have already undergone a previous
      surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or
      congenital sequelae in the hand or who do not have the capacity to understand the process or
      the tests to be performed will be excluded.

      The total expected duration of each patient in the study will be 6 months and the following
      visits and procedures will be carried out: clinical study and quality questionnaires prior to
      surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with
      repetition of clinical examination and quality questionnaires.

      The incidence of pillar pain (defined as 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) will be analyzed applying the principle of intention to treat,
      using the Mann Whitney test to compare the score in the tests used.
    

Intervention name(s): Z-plasty; Conventional
Intervention type(s): Procedure; Procedure
Intervention description(s): It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.; It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, using a computer-generated random assignment list
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Carpal Tunnel Syndrome; Pillar pain; Grip strength; Pincer strength