Recruitment

Recruitment Status
Completed
Estimated Enrollment
350

Inclusion Criteria

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
Control subjects without symptoms of carpal tunnel syndrome.
18 years or older and;
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
Control subjects without symptoms of carpal tunnel syndrome.
18 years or older and;

Exclusion Criteria

History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
Currently pregnant or < 3 months post partum
...
History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
Currently pregnant or < 3 months post partum
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
Implanted electronic device (pacemaker, intrathecal pump/stimulator)
Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation
Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
Any illness that makes it unsafe for the patient to participate in the study
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.
Known tumor, mass or deformity of the hand/wrist
Untreated hypothyroidism, Rheumatologic disorders

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

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
Control subjects without symptoms of carpal tunnel syndrome.
18 years or older and;
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
Control subjects without symptoms of carpal tunnel syndrome.
18 years or older and;

Exclusion Criteria

History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
Currently pregnant or < 3 months post partum
...
History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
Currently pregnant or < 3 months post partum
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
Implanted electronic device (pacemaker, intrathecal pump/stimulator)
Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation
Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
Any illness that makes it unsafe for the patient to participate in the study
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.
Known tumor, mass or deformity of the hand/wrist
Untreated hypothyroidism, Rheumatologic disorders

Tracking Information

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