Recruiting

Dynamic Splinting

Sponsor:

Advanced Centers for Orthopaedic Surgery and Sports Medicine

Code:

NCT00558116

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dynamic splinting

Study Details

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT00558116

Start date

May, 2007

Status verified date

May, 2008

Completion date

Dec, 2008

Anticipated

Primary completion date

Nov, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Treatment with Dynasplint device

no intervention: 2

Control group; does not receive conservative or surgical treatment.

Interventions

Dynamic splinting

The Dynasplint carpal tunnel device will be worn for 30 minutes, twice daily, for 60 consecutive days.

Primary outcome measure

  • Change in Nerve Conduction Test results [ Time Frame: 60 days ]

Central Contacts and Locations

Central contacts

Locations

Advanced Centers for Orthopaedic Surgery and Sports Medicine

Recruiting

Owings Mills, Maryland, United States, 21117

More Information

Sponsor

Advanced Centers for Orthopaedic Surgery and Sports Medicine

Last update posted

May 13, 2008

Last verified

May, 2008

Keywords

  • Carpal Tunnel Syndrome
  • Dynamic Splinting
  • Nerve Conduction Studies
  • Splinting
  • Levine Katz Survey

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Advanced Centers for Orthopaedic Surgery and Sports Medicine on 2008-05-13.