Treatment of Carpal Tunnel Syndrome With Dynamic Splinting

Official Title: “Treating Carpal Tunnel Syndrome With Dynamic Splinting: A Randomized, Controlled, Trial”

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.

This study will compare the efficacy of treating Carpal tunnel Syndrome with the Dynasplint® Systems device as compared to a non-treatment control group utilizing a randomized, controlled, cross-over study design. The dependant variables in this study are each patient's score on a Levine-Katz disability and pain scale test, and the change in nerve conduction of the median nerve that was tested upon diagnosis. The independent variables will include three different patient groups separated by randomization. The first group of subjects (selected randomly) will be fit with a therapeutic, functional Carpal Tunnel Dynasplint® versus the second, control patients will not be treated with dynamic splinting for the first sixty (60) days. After the initial sixty (60) days, the original control patients will be fit with a functional Carpal Tunnel Dynasplint® system and this will allow examiner to evaluate for further variance between subject groups, allowing the third group to be a Cross-Over group.

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.

Intervention(s) in this Clinical Trial

• Device: Dynamic splinting
  • The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Treatment with Dynasplint device
• No Intervention: 2
  • Control group; does not receive conservative or surgical treatment.

Primary Measures

• Change in Nerve Conduction Test results
  • Time Frame: 60 days
    Safety Issue?: No

Secondary Measures

• Change in score of Levine-Katz outcome survey
  • Time Frame: 60 days
    Safety Issue?: No

Inclusion Criteria:

• 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
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Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Advanced Centers for Orthopaedic Surgery and Sports Medicine Other

Overall Clinical Trial Officials and Contacts

Stacey H Berner, MD Principal Investigator Advanced Centers for Orthopaedic Surgery and Sports Medicine  

Overall Contact: Stacey H Berner, MD 410-484-8088 sberner@acossm.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00558116

Study ID Number: 101010

ClinicalTrials.gov Identifier: NCT00558116

Health Authority: Institutional Review Board, Lifebridgehealth USA: