Carpal Tunnel SyndromeNCT02907671
Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome
A study testing carpal tunnel corticoanesthetic injection in people with Carpal Tunnel Syndrome, run by Rehabilitace MUDr. Hasan Mezian s.r.o. at 2 sites in Czechia.
Trial summary
Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- carpal tunnel corticoanesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCzechia
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous steroid injection
- diabetes mellitus,
- thyroid disorder
- inflammatory disease
- polyneuropathy
- current pregnancy
Show all 9Show fewer
- previous carpal tunnel surgery
- severe illness
- inability to respond to questionnaires
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Kamal Mezian
Litoměřice, Czech Republic, 41201
Kamal Mezian, 603313207, kamal.mezian@gmail.com
- Recruiting
Kamal Mezian
Litoměřice, 41201
Kamal Mezian, 00420603313207, kamal.mezian@gmail.com
About this study
Official title: Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites
Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- carpal tunnel corticoanesthetic injection
- Keywords
- carpal tunnel injection, corticosteroid, ultrasound-guided, musculoskeletal ultrasound
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carpal tunnel corticoanesthetic injectionProcedure or surgery
Also called injetion with corticosteroid and local aneshtetics
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | carpal tunnel corticoanesthetic injection between the flexor tendons Receives: Procedure: carpal tunnel corticoanesthetic injection |
| Group B | Active comparator | carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection Receives: Procedure: carpal tunnel corticoanesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
pain severity scale
Measured: up to 1 year
Secondary outcomes (3)
Michigan Hand Outcomes Measure
Hand function status
Measured: up to 1 year
Boston carpal tunnel questionnaire
Hand function status
Measured: up to 1 year
Procedural CAS
discomfort during the internetion
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehabilitace MUDr. Hasan Mezian s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamal Mezian, M.D., Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907671
- Sponsor's protocol ID
- 111
- Status last verified
- Apr 2018
- First submitted
- 10 Sep 2016
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication in the relevant journal
Publications
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.
PubMed 27144462Podnar 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.
PubMed 26506508Bodor M, Rojo-Manaute JM, Podnar S. Reply. Muscle Nerve. 2016 Aug;54(2):344-5. doi: 10.1002/mus.25170. No abstract available.
PubMed 27144365
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites
- ClinicalTrials.gov ID
- NCT02907671
- Acronym / sponsor ID
- 111
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel injection, corticosteroid, ultrasound-guided, musculoskeletal ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rehabilitace MUDr. Hasan Mezian s.r.o.University, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: carpal tunnel corticoanesthetic injectioncarpal tunnel corticoanesthetic injection between the flexor tendons |
| Group B | Active comparator | Procedure: carpal tunnel corticoanesthetic injectioncarpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- previous steroid injection
- diabetes mellitus,
- thyroid disorder
- inflammatory disease
- polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carpal tunnel corticoanesthetic injectionAlso: injetion with corticosteroid and local aneshteticsDifferent Injection Sites (between the flexot tendons or around the median nerve with hydrodissection) | Procedure or surgery | Group A, Group B |
Primary outcome
Visual analogue scale
Time frame: up to 1 year
pain severity scale
3 secondary outcomes
Michigan Hand Outcomes Measure
Time frame: up to 1 year
Boston carpal tunnel questionnaire
Time frame: up to 1 year
Procedural CAS
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Results publication: PubMed 27144462Mezian 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.
- Results publication: PubMed 26506508Podnar 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.
- Results publication: PubMed 27144365Bodor M, Rojo-Manaute JM, Podnar S. Reply. Muscle Nerve. 2016 Aug;54(2):344-5. doi: 10.1002/mus.25170. No abstract available.
- Individual participant dataSharing planned: Yes. Publication in the relevant journal
Related trials for Carpal Tunnel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Mezian, M.D. principal investigator
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carpal tunnel corticoanesthetic injection in people with Carpal Tunnel Syndrome, run by Rehabilitace MUDr. Hasan Mezian s.r.o. at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamal Mezian, M.D. (00420603313207, kamal.mezian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907671, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.