Status:
COMPLETED
Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
Lead Sponsor:
Universidad de Zaragoza
Collaborating Sponsors:
Salud Aragon
Universitat de Catalunya
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A multicentric randomized controlled trial has been designed to study the effects of a decompression prototype splint on symptoms, functional capacity and nerve conduction studies in patients with car...
Detailed Description
A decompression prototype splint was designed to simulate an manual mobilization that is able to increase the CSA of the carpal tunnel and the median nerve in cadavers. These changes are important bec...
Eligibility Criteria
Inclusion
- Be medically diagnosed with carpal tunnel syndrome after electrophysiological tests and present mild to moderate involvement. This test is performed according to the standards established by the "American Academy of Physical Medicine and Rehabilitation"
- Ability to understand and communicate their symptoms and to complete the questionnaires.
Exclusion
- Previous surgery in the carpal tunnel in the same limb Other pathologies that may be associated with carpal tunnel syndrome: traumas, pathologies or disorders of the upper limb or cervical spine (cervical radiculopathy, cervical sprain, etc.) or prior cervical surgery
- Concurrent comorbidities that may be the cause and interfere with the treatment of the carpal tunnel syndrome: diabetes mellitus, hypothyroidism, rheumatoid arthritis, fibromyalgia, reflex sympathetic dysfunction, obesity, renal disease, alcoholism, significant vitamin deficiency and associated viral or bacterial processes
- Pregnancy
- Oral drugs, physiotherapy treatment , treatment with splints or infiltrations for carpal tunnel syndrome prior or during the study.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04043780
Start Date
September 24 2019
End Date
September 1 2020
Last Update
November 4 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Elena Estébanez de Miguel
Zaragoza, Spain, 50009