NCT02907671

Brief Summary

Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 10, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

September 10, 2016

Last Update Submit

April 17, 2018

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel injectioncorticosteroidultrasound-guidedmusculoskeletal ultrasound

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    pain severity scale

    up to 1 year

Secondary Outcomes (3)

  • Michigan Hand Outcomes Measure

    up to 1 year

  • Boston carpal tunnel questionnaire

    up to 1 year

  • Procedural CAS

    up to 1 year

Study Arms (2)

Group A

ACTIVE COMPARATOR

carpal tunnel corticoanesthetic injection between the flexor tendons

Procedure: carpal tunnel corticoanesthetic injection

Group B

ACTIVE COMPARATOR

carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection

Procedure: carpal tunnel corticoanesthetic injection

Interventions

carpal tunnel corticoanesthetic injectionPROCEDURE

Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)

Also known as: injetion with corticosteroid and local aneshtetics
Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary idiopathic CTS
  • symptoms of classic or probable CTS (numbness or tingling in at least 2 of the 4 radial fingers)
  • unsuccessful 1-month treatment with wrist splinting
  • nerve conduction test results that showed median neuropathy at the wrist

You may not qualify if:

  • previous steroid injection
  • diabetes mellitus,
  • thyroid disorder
  • inflammatory disease
  • polyneuropathy
  • current pregnancy
  • previous carpal tunnel surgery
  • severe illness
  • inability to respond to questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kamal Mezian

Litoměřice, Czech Republic, 41201, Czechia

RECRUITING

Kamal Mezian

Litoměřice, 41201, Czechia

RECRUITING

Related Publications (3)

  • Mezian K, Bruthans J. Why do local corticosteroid injections work in carpal tunnel syndrome, But not in ulnar neuropathy at the elbow? Muscle Nerve. 2016 Aug;54(2):344. doi: 10.1002/mus.25171. Epub 2016 May 26. No abstract available.

    PMID: 27144462RESULT

  • Podnar S, Omejec G. Why do local corticosteroid injections work in carpal tunnel syndrome, but not in ulnar neuropathy at the elbow? Muscle Nerve. 2016 Apr;53(4):662-3. doi: 10.1002/mus.24956. No abstract available.

    PMID: 26506508RESULT

  • Bodor M, Rojo-Manaute JM, Podnar S. Reply. Muscle Nerve. 2016 Aug;54(2):344-5. doi: 10.1002/mus.25170. No abstract available.

    PMID: 27144365RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Kamal Mezian, M.D.

    Czech Technical University in Prague, Faculty of Biomedical Engineering, Department of Health Care Disciplines and Population Protection, Sportovců 2311, 272 01 Kladno city, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamal Mezian, M.D.

CONTACT

00420603313207kamal.mezian@gmail.com

Study Design

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

Study Record Dates

First Submitted

September 10, 2016

First Posted

September 20, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Publication in the relevant journal

Locations

CZ(2)