Treatment of Carpal Tunnel Syndrome With Dynamic Splinting
NCT ID: NCT00558116
Last Updated: 2008-05-13
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2007-05-31
2008-12-31
Brief Summary
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Detailed Description
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The METHODS for this multi-centered study include recruiting patients from multiple hand surgeons and neurologists and these patients will have been diagnosed with following the physicians' physical examination and a nerve conduction test of the median nerve. The subjects then will be briefed on this study and sign an informed consent as required by the IRB before participating. Subjects who do consent will then be given the Levine-Katz disability and pain scale test, and prior to being fit with the Carpal Tunnel Dynasplint® Subjects will be taught how to use a Carpal Tunnel Dynasplint® properly and after being fit with the Carpal Tunnel Dynasplint® each subject will be required to complete a weekly report showing compliance to the wearing and treatment schedule, and they must attend regular, monthly examinations by the referring physician. After the initial sixty (60) days in the study each subject will repeat the three lead conduction test of the median nerve.
Control subjects at this point will be fit with the Carpal Tunnel Dynasplint® systems becoming Cross-Over subjects and their final nerve conduction test will be administered after they have worn the Carpal Tunnel Dynasplint® system for sixty (60) days. Upon discharge from this study all subjects will also retake the Levine-Katz disability and pain scale test.
Eighty (80) SUBJECTS will be recruited following diagnosis of CTS (using nerve conduction testing of the median nerve for differential diagnosis) and group assignment will be determined through randomization following each patient's completion of the informed consent required by the IRB. All patients randomly selected to start in the experimental group will be fit with functional Carpal Tunnel Dynasplint® and the control group subjects will not be fit until after sixty (60) days. When they are ultimately fit, they will then be categorized as "Cross-Over" subjects to measure continued variance between all groups.
The DURATION for patients enrolled in this study will be sixty (60) days for the experimental subjects and the control subjects will spend their first sixty (60) days as a control role without treatment. However, following sixty days the initial control subjects but then they will be refit with a functional Carpal Tunnel Dynasplint® as a "Cross-Over" subject for an additional sixty (60) days, which makes the control subjects duration in this study 120 days.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
Treatment with Dynasplint device
Dynamic splinting
The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
2
Control group; does not receive conservative or surgical treatment.
Dynamic splinting
The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
Interventions
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Dynamic splinting
The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
Eligibility Criteria
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Inclusion Criteria
* Patients will be ≥18 years old and of either gender
* Patients will agree and be able to sign a voluntary consent to participate form
* Nerve Conduction study results as follows:
Sensory conduction latency to peak greater than 3.7ms when measured with ring pick up on the volar surface of the index finger measured 14cm from stimulation across the wrist at the median nerve Motor conduction latency to take off greater than 4.2ms when measured with disc pick up on the abductor pollicis brevis muscle measured 8 cm from stimulation across the wrist at the median nerve
\-
Exclusion Criteria
* Patients that are currently undergoing manual, hand therapy
* Patients that have been previously diagnosed with cervical radiculopathy
* Patients whose examination shows evidence of a "Double Crush" syndrome
* Pregnancy
* Nerve Conduction study results as follows:
Sensory conduction latency to peak less than 3.7ms when measured with ring pick up on the volar surface of the index finger measured 14cm from stimulation across the wrist at the median nerve Motor conduction latency to take off less than 4.2ms when measured with disc pick up on the abductor pollicis brevis muscle measured 8cm from stimulation across the wrist at the median nerve
18 Years
ALL
Yes
Sponsors
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Dynasplint Systems, Inc.
INDUSTRY
Advanced Centers for Orthopaedic Surgery and Sports Medicine
OTHER
Responsible Party
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Advanced Centers for Orthopaedic Surgery and Sports Medicine
Principal Investigators
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Stacey H Berner, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Centers for Orthopaedic Surgery and Sports Medicine
Locations
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Advanced Centers for Orthopaedic Surgery and Sports Medicine
Owings Mills, Maryland, United States
Countries
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Central Contacts
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Other Identifiers
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101010
Identifier Type: -
Identifier Source: org_study_id