Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome

NCT ID: NCT02708693

Last Updated: 2016-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental: steroid injection and splinting

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint

Group Type EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)

thermoplastic wrist splint

Intervention Type DEVICE

thermoplastic wrist splint with wrist placed in a neutral position

lidocaine hydrochloride

Intervention Type DRUG

ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)

steroid injection

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)

lidocaine hydrochloride

Intervention Type DRUG

ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Interventions

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Triamcinolone Acetonide

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)

Intervention Type DRUG

thermoplastic wrist splint

thermoplastic wrist splint with wrist placed in a neutral position

Intervention Type DEVICE

lidocaine hydrochloride

ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Intervention Type DRUG

Other Intervention Names

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triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan) lidocaine hydrochloride (Xylocaine)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2012-05-021A

Identifier Type: -

Identifier Source: org_study_id

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