Clinical trial NCT04043780: Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
Official title: Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome: a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Salud Aragon
name: Universitat de Catalunya
name: Institut Català de la Salut
First posted: 2019-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 carpal tunnel syndrome.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of symptoms at baseline
timeFrame: Baseline
measure: Intensity of the symptoms at 6 weeks
timeFrame: 6 weeks
measure: Intensity of the symptoms at 4 months
timeFrame: 4 months
measure: Nerve conduction studies at baseline
timeFrame: Baseline
measure: Nerve conduction studies at 6 weeks
timeFrame: 6 weeks
measure: Self-reported symptom severity and functional status at baseline
timeFrame: Baseline
measure: Self-reported symptom severity and functional status at 6 weeks
timeFrame: 6 weeks
measure: Self-reported symptom severity and functional status at 4 months
timeFrame: 4 months
measure: Global Perceived Effect at 6 weeks
timeFrame: 6 weeks
measure: Global Perceived Effect at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Adherence to the treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Elena Estébanez de Miguel
Study officials:
affiliation: Universidad de Zaragoza
name: Elena Estébanez-de-Miguel, PhD
role: PRINCIPAL_INVESTIGATOR
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