Clinical trial NCT02708693: Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
Official title: Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-03-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome

Detailed description: This is a prospective, single-blinded randomized controlled study. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection and group receiving ultrasound guided corticosteroid injection and splinting. The steroid injection was using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine). The inclusion criteria included an age of more than 18 years and typical signs of CTS according to American Academy of Neurology criteria lasting for at least 3 months. The diagnosis of CTS was confirmed by electrophysiological tests.The exclusion criteria included the following: presence of thenar atrophy; existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome; prior steroid injection into the affected carpal tunnel or carpal tunnel surgery; history of distal radius fracture; pregnancy or lactation; regular use of systemic NSAIDs or corticosteroids; and known allergy to corticosteroids and local anesthetics.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of CTS
2. The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

1. presence of thenar atrophy
2. existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
3. prior steroid injection into the affected carpal tunnel or carpal tunnel surgery
4. history of distal radius fracture
5. pregnancy or lactation
6. regular use of systemic NSAIDs or corticosteroids
7. known allergy to corticosteroids and local anesthetics.

Primary outcomes:
measure: Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
timeFrame: at 2, 6, 12 weeks
Secondary outcomes:
measure: Change from Baseline in Median nerve distal motor latency
timeFrame: at 2, 6, 12 weeks
measure: Change from Baseline in sensory nerve conduction velocity
timeFrame: at 2, 6, 12 weeks
measure: Change from Baseline in compound muscle action potential amplitude (CMAP)
timeFrame: at 2, 6, 12 weeks
measure: Change from Baseline in sensory nerve action potential amplitudes.
timeFrame: at 2, 6, 12 weeks
measure: Change from Baseline in self-reported pain intensity
timeFrame: at 2, 6, 12 weeks
measure: change from Baseline in Cross sectional area
timeFrame: at 2, 6, 12 weeks
measure: change from Baseline in flattening ratio
timeFrame: at 2, 6, 12 weeks
Other outcomes:
Locations:
Study officials:
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