Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
NCT ID: NCT04043780
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-09-24
2020-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Decompression prototype splint
The patients of this group will wear the decompression prototype splint.
Decompression prototype splint for carpal tunnel syndrome
This group will wear during 6 weeks a decompression prototype splint. They we be informed to wear it as long as possible during the 6 weeks.
standard splint
The patients of this group will wear a standard splint.
Standard splint for carpal tunnel syndrome
This group will wear during 6 weeks a standard splint. They we be informed to wear it as long as possible during the 6 weeks.
Interventions
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Decompression prototype splint for carpal tunnel syndrome
This group will wear during 6 weeks a decompression prototype splint. They we be informed to wear it as long as possible during the 6 weeks.
Standard splint for carpal tunnel syndrome
This group will wear during 6 weeks a standard splint. They we be informed to wear it as long as possible during the 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and communicate their symptoms and to complete the questionnaires.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Salud Aragon
UNKNOWN
Universitat de Catalunya
UNKNOWN
Institut Català de la Salut
OTHER
Universidad de Zaragoza
OTHER
Responsible Party
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Elena Estebanez de Miguel
Principal Investigator
Principal Investigators
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Elena Estébanez-de-Miguel, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Zaragoza
Locations
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Elena Estébanez de Miguel
Zaragoza, , Spain
Countries
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References
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Other Identifiers
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PI19/334
Identifier Type: -
Identifier Source: org_study_id