Corticosteroid Injection in Carpal Tunnel Syndrome

NCT ID: NCT03072290

Last Updated: 2019-07-30

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-18

Study Completion Date

2018-12-20

Brief Summary

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To compare the effectiveness of different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation

Detailed Description

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This is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with CTS. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (Shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. The follow up at 6 and 12 weeks includes Boston Carpal Tunnel Questionnaire, nerve conductive study and VAS pain score.

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

DOUBLE

Participants Outcome Assessors

Study Groups

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low dose steroid

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 EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type DRUG

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)

lidocaine hydrochloride

Intervention Type DRUG

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

comparator

ultrasound-guided steroid injection using 1ml of 40 mg (40mg/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) or 40 mg (40 mg/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) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)

Intervention Type DRUG

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

* Clinical diagnosis of CTS
* The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria

* 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 within 6 months or ever received carpal tunnel surgery
* history of distal radius fracture
* pregnancy or lactation
* regular use of systemic NSAIDs ,corticosteroids or diuretics
* known allergy to corticosteroids and local anesthetics.
* impaired cognitive function
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

Locations

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Taipei veteran general hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsu PC, Liao KK, Lin KP, Chiu JW, Wu PY, Chou CL, Wang NY, Wang JC. Comparison of Corticosteroid Injection Dosages in Mild to Moderate Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1857-1864. doi: 10.1016/j.apmr.2020.06.018. Epub 2020 Jul 16.

Reference Type DERIVED
PMID: 32682938 (View on PubMed)

Other Identifiers

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2016-07-006A

Identifier Type: -

Identifier Source: org_study_id

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