Recruitment

Recruitment Status
Completed
Estimated Enrollment
350

Inclusion Criteria

18 years or older and;
Control subjects without symptoms of carpal tunnel syndrome.
Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing
18 years or older and;
Control subjects without symptoms of carpal tunnel syndrome.
Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing

Exclusion Criteria

Diagnosed neuromuscular disorders which may complicate CTS diagnosis
History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
...
Diagnosed neuromuscular disorders which may complicate CTS diagnosis
History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Any illness that makes it unsafe for the patient to participate in the study
Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.
Currently pregnant or < 3 months post partum
Known tumor, mass or deformity of the hand/wrist
Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
Untreated hypothyroidism, Rheumatologic disorders
Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation
Implanted electronic device (pacemaker, intrathecal pump/stimulator)

Summary

Conditions
Carpal Tunnel Syndrome
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

18 years or older and;
Control subjects without symptoms of carpal tunnel syndrome.
Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing
18 years or older and;
Control subjects without symptoms of carpal tunnel syndrome.
Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing

Exclusion Criteria

Diagnosed neuromuscular disorders which may complicate CTS diagnosis
History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
...
Diagnosed neuromuscular disorders which may complicate CTS diagnosis
History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Any illness that makes it unsafe for the patient to participate in the study
Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.
Currently pregnant or < 3 months post partum
Known tumor, mass or deformity of the hand/wrist
Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
Untreated hypothyroidism, Rheumatologic disorders
Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation
Implanted electronic device (pacemaker, intrathecal pump/stimulator)

Tracking Information

NCT #
NCT02038205
Collaborators
Not Provided
Investigators
  • Principal Investigator: Nanette Joyce, DO University of California, Davis
  • Nanette Joyce, DO University of California, Davis
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