Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome

University of Zaragoza

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Device: Decompression prototype splint for carpal tunnel syndrome; Device: Standard splint for carpal tunnel syndrome

Study type: Interventional

Funder types: Other

Identifiers

NCT04043780

PI19/334

Details and patient eligibility

About

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 carpal tunnel syndrome.

Full 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 because they may relate to the decrease in CTS symptoms.

Patients with mild or moderate carpal tunnel syndrome will be selected for the trial. They will be randomized in 2 groups. One group will wear an standard splint for carpal tunnel syndrome and the other the decompression prototype splint.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Decompression prototype splint

Experimental group

Description:

The patients of this group will wear the decompression prototype splint.

Treatment:

Device: Decompression prototype splint for carpal tunnel syndrome

standard splint

Active Comparator group

Description:

The patients of this group will wear a standard splint.

Treatment:

Device: Standard splint for carpal tunnel syndrome