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Trial record 4 of 193 for:    Carpal Tunnel Syndrome

Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02907671
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Rehabilitace MUDr. Hasan Mezian s.r.o.

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: carpal tunnel corticoanesthetic injection Not Applicable

Detailed Description:
Carpal tunnel syndrome (CTS) is the most common nerve entrapment neuropathy. Six placebo-controlled trials with 393 participants proved corticosteroid injection to be effective in symptom relief. However, all injections were palpation-guided. Therefore, the exact injection site was uncertain. Although three studies comparing palpation and ultrasound (US) guided CTS injection showed US superiority, the optimal injection site for the injectate delivery remains unclear. Some authors believe in thinning of the flexor tenosynovium as the mechanism of the median nerve decompression, and therefore recommend injection between the tendons, away from the nerve. Other authors stress the importance of hydrodissection and direct contact of the injectate with the nerve and suggest injection targeting the median nerve. According to our best knowledge, no study comparing different injection sites for a corticosteroid delivery in CTS has been published in English written literature. The objective of this study was to determine the optimal target site for the corticosteroid delivery in CTS injection.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Group A
carpal tunnel corticoanesthetic injection between the flexor tendons
Procedure: carpal tunnel corticoanesthetic injection
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
Other Name: injetion with corticosteroid and local aneshtetics

Active Comparator: Group B
carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection
Procedure: carpal tunnel corticoanesthetic injection
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
Other Name: injetion with corticosteroid and local aneshtetics




Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: up to 1 year ]
    pain severity scale


Secondary Outcome Measures :
  1. Michigan Hand Outcomes Measure [ Time Frame: up to 1 year ]
    Hand function status

  2. Boston carpal tunnel questionnaire [ Time Frame: up to 1 year ]
    Hand function status

  3. Procedural CAS [ Time Frame: up to 1 year ]
    discomfort during the internetion



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907671


Contacts
Contact: Kamal Mezian, M.D. 00420603313207 kamal.mezian@gmail.com

Locations
Czechia
Kamal Mezian Recruiting
Litoměřice, Czech Republic, Czechia, 41201
Contact: Kamal Mezian    603313207    kamal.mezian@gmail.com   
Kamal Mezian Recruiting
Litomerice, Czechia, 41201
Contact: Kamal Mezian    00420603313207    kamal.mezian@gmail.com   
Sponsors and Collaborators
Rehabilitace MUDr. Hasan Mezian s.r.o.
Investigators
Principal Investigator: 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

Publications of Results:
Responsible Party: Rehabilitace MUDr. Hasan Mezian s.r.o.
ClinicalTrials.gov Identifier: NCT02907671     History of Changes
Other Study ID Numbers: 111
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in the relevant journal

Keywords provided by Rehabilitace MUDr. Hasan Mezian s.r.o.:
carpal tunnel injection
corticosteroid
ultrasound-guided
musculoskeletal ultrasound

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries