Carpal Tunnel SyndromeSTC-EINCT02036125
Carpal Tunnel Syndrome - Randomized Clinical Trial Evaluating Effectiveness of Ultrasound in Corticosteroid Injection
A study testing Ultrasound and methylprednisolone in people with Carpal Tunnel Syndrome, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Ultrasound and methylprednisolone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Dec 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65
- Understanding written and spoken french
- Diagnostic of carpal tunnel syndrome : Classic of probable based on the Katz Hand Diagram and mild to moderate based on the electrodiagnosis studies
Who cannot join
- Carpal tunnel injection in the last 6 months
- Constant symptoms in medial nerve area
- Thenar eminence atrophy
- Absolute contraindication to corticosteroid injection : infective arthritis, bacterial endocarditis, local cellulitis of skin infection, coagulopathy, corticosteroid or latex allergy
- Secondary diagnosis based on the ultrasound : arthrosynovial cyst, flexor tenosynovitis, ganglion
- Known cognitive disorder
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- Anticoagulant therapy
- Diseases known to cause carpal tunnel syndrome : Diabetes mellitus, hypothyroidism, connective tissue disease, rheumatic disease and moderate or severe chronic renal impairment
- Radiculopathy
- Polyneuropathy
- Pregnancy
- Ancient ipsilateral wrist fracture
- Ancient ipsilateral wrist surgery
Trial locations and contacts
1 site in 1 country.
Alessandra Bruns, MD, FRCPC contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Alessandra Bruns, MD, FRCPC, 819 564 5261
Anne-Marie Pitre-Joyal, MD, 418 649 0252 ext. 5751
About this study
Official title: Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes
The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.
Read the detailed description
Corticosteroid injection is routinely given for treating carpal tunnel syndrome. The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.
In this randomised clinical trial, 50 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from the Centre Hospitalier Universitaire de Sherbrooke (CHUS). Subjects will be randomised to ultrasound guided or blind injection groups. All subjects will receive 40 mg of methylprednisolone. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline and 3 months post injection. Both subjects and assessors will be blinded.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasound, methylprednisolone
- Keywords
- Corticosteroid, Ultrasound, Guided injection
- 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.
UltrasoundDevice
Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.
Subjects will receive a blind injection of 40 mg of methylprednisolone.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided injection | Experimental | Ultrasound guided injection of 40 mg of methylprednisolone Receives: Device: Ultrasound; Drug: methylprednisolone |
| Blind injection | Active comparator | Blind injection of 40 mg of methylprednisolone Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
Measured: 3 months
Secondary outcomes (8)
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
Measured: 3 months
DASH questionnaire
Measured: 3 months
Numeric Pain Rating Scale
Mean pain felt in the last 2 weeks
Measured: 3 months
Ultrasound measured medial nerve area in carpal tunnel
Measured: 3 months
Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel
Measured: 3 months
Ultrasound hypervascularisation of medial nerve in carpal tunnel
Measured: 3 months
Numeric Pain Rating Scale
Pain during injection
Measured: Baseline
Global Rating of Change
The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Bruns, Université de Sherbrooke
- Investigators
- Alessandra Bruns, Md, FRCPC, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036125
- Sponsor's protocol ID
- 13-143
- Acronym
- STC-EI
- Status last verified
- Dec 2014
- First submitted
- 11 Jan 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes
- ClinicalTrials.gov ID
- NCT02036125
- Acronym / sponsor ID
- STC-EI / 13-143
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Corticosteroid, Ultrasound, Guided injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Jan 2014 (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.
The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.
Detailed description
Corticosteroid injection is routinely given for treating carpal tunnel syndrome. The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.
In this randomised clinical trial, 50 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from the Centre Hospitalier Universitaire de Sherbrooke (CHUS). Subjects will be randomised to ultrasound guided or blind injection groups. All subjects will receive 40 mg of methylprednisolone. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline and 3 months post injection. Both subjects and assessors will be blinded.
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 |
|---|---|---|
| Ultrasound guided injection | Experimental | Device: Ultrasound, Drug: methylprednisoloneUltrasound guided injection of 40 mg of methylprednisolone |
| Blind injection | Active comparator | Drug: methylprednisoloneBlind injection of 40 mg of methylprednisolone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65
- Understanding written and spoken french
- Diagnostic of carpal tunnel syndrome : Classic of probable based on the Katz Hand Diagram and mild to moderate based on the electrodiagnosis studies
Key exclusion criteria (13 listed)
- Carpal tunnel injection in the last 6 months
- Constant symptoms in medial nerve area
- Thenar eminence atrophy
- Absolute contraindication to corticosteroid injection : infective arthritis, bacterial endocarditis, local cellulitis of skin infection, coagulopathy, corticosteroid or latex allergy
- Secondary diagnosis based on the ultrasound : arthrosynovial cyst, flexor tenosynovitis, ganglion
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 |
|---|---|---|
| UltrasoundSubjects will receive an ultrasound guided injection of 40 mg of methylprednisolone. | Device | Ultrasound guided injection |
| methylprednisoloneSubjects will receive a blind injection of 40 mg of methylprednisolone. | Drug | Blind injection, Ultrasound guided injection |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
Time frame: 3 months
The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
8 secondary outcomes
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
Time frame: 3 months
DASH questionnaire
Time frame: 3 months
Numeric Pain Rating Scale
Time frame: 3 months
Ultrasound measured medial nerve area in carpal tunnel
Time frame: 3 months
Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel
Time frame: 3 months
Ultrasound hypervascularisation of medial nerve in carpal tunnel
Time frame: 3 months
Numeric Pain Rating Scale
Time frame: Baseline
Global Rating of Change
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Alessandra Bruns, MD, FRCPC contact
Alessandra Bruns, Md, FRCPC principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and methylprednisolone in people with Carpal Tunnel Syndrome, run by Université de Sherbrooke at 1 site in Canada.
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 3 inclusion and 13 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 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Alessandra Bruns, MD, FRCPC (819 564 5261), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2014.