NCT03132051

Brief Summary

The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 27, 2017

Status Verified

February 1, 2017

Enrollment Period

4.8 years

First QC Date

February 16, 2017

Last Update Submit

April 24, 2017

Conditions

Keywords

carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

  • Cross sectional area

    The CSA of the median nerve was measured at 2 levels: at the carpal tunnel inlet (CSA-I; immediately prior to the proximal margin of the flexor retinaculum) and in the mid-carpal tunnel (CSA-M; at the level of the pisiform bone and scaphoid tubercle)

    12 weeks

Secondary Outcomes (6)

  • flattening ratio

    2, 6, 12 weeks

  • Boston Carpal Tunnel Questionnaire (BQ)

    2, 6, 12 weeks

  • Median nerve distal motor latency

    2, 6, 12 weeks

  • sensory nerve conduction velocity

    2, 6, 12 weeks

  • compound muscle action potential amplitude (CMAP)

    2, 6, 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

steroid injection

EXPERIMENTAL

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

Drug: steroid injection

Interventions

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

Also known as: triamcinolone acetonide
steroid injection

Eligibility Criteria

Age18 Years - 80 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:

  • neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
  • history of distal radius fracture
  • pregnancy or lactation
  • regular use of systemic NSAIDs or corticosteroids
  • known allergy to corticosteroids and local anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

SteroidsTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsTriamcinolonePregnadienesPregnanesSteroids, Fluorinated

Study Officials

  • Jia chi Wang

    Taipei Veteran General hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia chi Wang, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients received steroid injection for carpel tunnel syndrome (CTS) and ultrasonographic evaluation before and after steroid injection
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

April 27, 2017

Study Start

April 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 27, 2017

Record last verified: 2017-02

Locations