Treatment of Carpal Tunnel Syndrome With Dynamic Splinting
Treating Carpal Tunnel Syndrome With Dynamic Splinting: A Randomized, Controlled, Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
The Purpose of this study is to examine the effect of using the Carpal Tunnel Dynasplint® System on patients diagnosed with CTS in a randomized, controlled, cross-over study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 12, 2007
CompletedFirst Posted
Study publicly available on registry
November 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMay 13, 2008
May 1, 2008
1.5 years
November 12, 2007
May 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Nerve Conduction Test results
60 days
Secondary Outcomes (1)
Change in score of Levine-Katz outcome survey
60 days
Study Arms (2)
1
EXPERIMENTALTreatment with Dynasplint device
2
NO INTERVENTIONControl group; does not receive conservative or surgical treatment.
Interventions
The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.
Eligibility Criteria
You may qualify if:
- Patients must exhibit one of the following symptoms of CTS: numbness, tingling, or pain in the wrist or hand
- 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
You may not qualify if:
- Patients that have thenar atrophy of the hand
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Advanced Centers for Orthopaedic Surgery and Sports Medicine
Owings Mills, Maryland, 21117, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacey H Berner, MD
Advanced Centers for Orthopaedic Surgery and Sports Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 12, 2007
First Posted
November 14, 2007
Study Start
May 1, 2007
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
May 13, 2008
Record last verified: 2008-05