Danielle Soares Figueiredo1, Marcia Aparecida Ciol2, Maria da Conceição Dos Santos3, Letícia de Araújo Silva4, Joseph Bruno Bidin Brooks5, Roger Amorim Santos Diniz6, Helga Tatiana Tucci7. 1. Department of Human Movement Science, Universidade Federal de São Paulo, Santos, Brazil; Rua Silva Jardim, nº 136, Vila Mathias, Santos, São Paulo, CEP 11015-020, Brazil. Electronic address: dani.figueiredo16@yahoo.com.br. 2. Department of Rehabilitation Medicine, School of Medicine, University of Washington, Seattle, USA; 1959 NE Pacific St, UW Box, 356490, Seattle, WA, 98195-6490, USA. Electronic address: marciac@uw.edu. 3. Department of Human Movement Science, Universidade Federal de São Paulo, Santos, Brazil; Rua Silva Jardim, nº 136, Vila Mathias, Santos, São Paulo, CEP 11015-020, Brazil. Electronic address: mariasantosto@uol.com.br. 4. Department of Human Movement Science, Universidade Federal de São Paulo, Santos, Brazil; Rua Silva Jardim, nº 136, Vila Mathias, Santos, São Paulo, CEP 11015-020, Brazil. Electronic address: leticiaaraujos@hotmail.com. 5. Faculty of Medicine, Universidade Metropolitana de Santos, Santos, Brazil; Rua da Constituição, nº 374, Vila Nova, Santos, São Paulo, CEP 11015-470, Brazil. Electronic address: joseph3b@gmail.com. 6. Faculty of Medicine, Universidade Metropolitana de Santos, Santos, Brazil; Rua da Constituição, nº 374, Vila Nova, Santos, São Paulo, CEP 11015-470, Brazil. Electronic address: rod.diniz@uol.com.br. 7. Department of Human Movement Science, Universidade Federal de São Paulo, Santos, Brazil; Rua Silva Jardim, nº 136, Vila Mathias, Santos, São Paulo, CEP 11015-020, Brazil. Electronic address: helgatucci@gmail.com.
Abstract
BACKGROUND:Conservative treatment for carpal tunnel syndrome (CTS) often includes wrist orthosis. However, there is no consensus on whether commercial or custom-made wrist orthosis is better for the treatment. PURPOSE: To assess feasibility of a study comparing nocturnal use of commercial versus custom-made wrist orthosis in the treatment of mild/moderate CTS and estimate their potential effects on function and symptoms. STUDY DESIGN: Randomized clinical trial. METHODS:Twenty-four individuals with mild/moderate CTS were randomized to wear either a commercial orthosis (n = 12) or a custom-made orthosis (n = 12). Participants used the assigned orthosis at night for 45 days and performed gliding exercises at home/work. We collected data on access to eligible population and feasibility of protocol. Data on use of orthosis, performance of exercises, and symptoms were collected through a dairy filled by the participant. Outcomes were pain (using Numeric Pain Rating Scale), symptom severity and functional status (using Boston Questionnaire), pinch strength (by dynamometry), and electromyographic activity of forearm muscles (sampled during a reach-to-grasp task). Outcomes were measured before and after the intervention. RESULTS: There were no loses to follow-up in either intervention group. After treatment, we found increased tripod pinch strength and better symptoms and function in both orthosis groups, with better outcomes for the custom-made orthosis, although the differences were not statistically significant. CONCLUSIONS: The preliminary results showed a potential for better outcomes from the custom-made orthosis. We established that a larger study would be feasible and could be designed and conducted based on the estimates provided by this study. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) - registration number: RBR-74rqnz.
RCT Entities:
BACKGROUND: Conservative treatment for carpal tunnel syndrome (CTS) often includes wrist orthosis. However, there is no consensus on whether commercial or custom-made wrist orthosis is better for the treatment. PURPOSE: To assess feasibility of a study comparing nocturnal use of commercial versus custom-made wrist orthosis in the treatment of mild/moderate CTS and estimate their potential effects on function and symptoms. STUDY DESIGN: Randomized clinical trial. METHODS: Twenty-four individuals with mild/moderate CTS were randomized to wear either a commercial orthosis (n = 12) or a custom-made orthosis (n = 12). Participants used the assigned orthosis at night for 45 days and performed gliding exercises at home/work. We collected data on access to eligible population and feasibility of protocol. Data on use of orthosis, performance of exercises, and symptoms were collected through a dairy filled by the participant. Outcomes were pain (using Numeric Pain Rating Scale), symptom severity and functional status (using Boston Questionnaire), pinch strength (by dynamometry), and electromyographic activity of forearm muscles (sampled during a reach-to-grasp task). Outcomes were measured before and after the intervention. RESULTS: There were no loses to follow-up in either intervention group. After treatment, we found increased tripod pinch strength and better symptoms and function in both orthosis groups, with better outcomes for the custom-made orthosis, although the differences were not statistically significant. CONCLUSIONS: The preliminary results showed a potential for better outcomes from the custom-made orthosis. We established that a larger study would be feasible and could be designed and conducted based on the estimates provided by this study. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) - registration number: RBR-74rqnz.