NCT03072290

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

March 1, 2017

Last Update Submit

July 28, 2019

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).

    The BQ was interviewed-administered to assess the severity of symptoms and functional status.

    at 6, 12 weeks

Secondary Outcomes (4)

  • Change from Baseline in Median nerve distal motor latency

    at 6, 12 weeks

  • Change from Baseline in sensory nerve conduction velocity

    at 6, 12 weeks

  • Change from Baseline in compound muscle action potential amplitude (CMAP)

    at 6, 12 weeks

  • Change from Baseline in self-reported pain intensity

    at 6, 12 weeks

Study Arms (2)

low dose steroid

EXPERIMENTAL

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

Drug: Triamcinolone AcetonideDrug: lidocaine hydrochloride

comparator

ACTIVE COMPARATOR

ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Drug: Triamcinolone AcetonideDrug: lidocaine hydrochloride

Interventions

Triamcinolone AcetonideDRUG

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

Also known as: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)
comparatorlow dose steroid
lidocaine hydrochlorideDRUG

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

Also known as: lidocaine hydrochloride (Xylocaine)
comparatorlow dose steroid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei veteran general hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 32682938DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Triamcinolone AcetonideLidocaine

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 7, 2017

Study Start

February 18, 2017

Primary Completion

November 28, 2018

Study Completion

December 20, 2018

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

TW(1)