Carpal Tunnel SyndromeNCT05556278
Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
An observational study of Carpal Tunnel Syndrome, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
The main objective is to investigate the value of ultrasound in the diagnosis of Carpal Tunnel Syndrome (CTS), and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Ultrasound study and Neurophysiological test
- How many people
- 438 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to 31 May 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical suspicion of CTS that come consecutively from the Neurophysiology Department of the Virgen Macarena Hospital in Seville (Spain).
Who may be able to join
- Presenting clinical symptoms suggestive of CTS, at least one of the following:
- Neuropathic profile pain in wrist-hand at the level of the median nerve territory (wrist, first-second-third, and radial half of the fourth finger by palmar and/or volar side), possibility of irradiation of the pain towards the forearm and/or arm.
- Nocturnal symptoms.
- Hypotrophy or atrophy of the thenar eminence.
- Self-described sensory alteration (sensation of cramping, numbness, tingling, hypoalgesia or analgesia).
- Age: 18 to 75 years.
- Consent to participate in the study.
Who cannot join
- Previous surgery on the wrist
- Acquired or hereditary pathology causing peripheral neuropathies
- Polyneuropathy of any etiology
- Rheumatoid arthritis
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de la Macarena
Seville, 41009
María de la Paz Murciano Casas, MD, +34 955 00 80 00, maripazmurciano@gmail.com
Manuel Rodríguez-Piñero Durán, MD, +34 955 00 80 00, manuel.rodriguezpinero.sspa@juntadeandalucia.es
About this study
The main objective is to investigate the value of ultrasound in the diagnosis of Carpal Tunnel Syndrome (CTS), and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values that determine the presence or absence of CTS. Finally, cost-effectiveness analysis is proposed.
Read the detailed description
The reference test with which the ultrasound is compared is the neurophysiological test (NPT).
The expected timeline for the study is to be performed between July 2020 and May 2023.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Ultrasound study, Neurophysiological test
- Keywords
- carpal tunnel syndrome, nerve conduction study, ultrasound, screening, diagnosis
- Medical subject headings
- Carpal Tunnel Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound studyDiagnostic test
based on the recommendations of the American Association of Electrodiagnostic Medicine (AAEM) (1)
Neurophysiological testDiagnostic test
Also called Nerve conduction study
ultrasound protocol described by Chen et al. (2)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | An electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria. Receives: Diagnostic Test: Ultrasound study; Diagnostic Test: Neurophysiological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic variables
Sex, age, time of evolution of the clinic, manual dominance, hand affected, body mass index, employment status, type of work (pink, white or blue collar), time worked, triggers of symptoms, what symptoms are relieved with, as well as toxic habits, whether they are smokers (to be answered affirmative or negative) or alcohol consumers (to be answered affirmative or negative).
Measured: January 2021 to September 2022
Electrodiagnostic variables
Motor conduction velocity of the median nerve (calculating distal motor latency and wrist-elbow motor conduction velocity), motor conduction velocity of the ulnar nerve (calculating distal motor latency, lower and upper wrist-elbow motor conduction velocity), orthodromic sensory conduction of the median, ulnar and radial nerve, as well as antidromic sensory conduction of the median, ulnar and radial nerve.
Measured: January 2021 to September 2022
Ultrasound variables
The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches
Measured: January 2021 to September 2022
Boston Carpal Tunnel Questionnaire
Measured: January 2021 to September 2022
Cost evaluation
Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests
Measured: From September 2022 to May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Jul 2020
- Primary completion30 Oct 2022 (estimated)
- Study completion31 May 2023 (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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556278
- Sponsor's protocol ID
- RHB-02/2019
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol can be accessed by contacting the trial team at (e-mail). Anonymized participants level data and statistical codes used for the analysis are available on request and subject to data sharing agreements. Data sharing may only be possible after relevant embedded trials have been published.
Publications
American Association of Electrodiagnostic Medicine, American Academy of Neurology, and American Academy of Physical Medicine and Rehabilitation. Practice parameter for electrodiagnostic studies in carpal tunnel syndrome: summary statement. Muscle Nerve. 2002 Jun;25(6):918-22. doi: 10.1002/mus.10185. No abstract available.
PubMed 12115985Chen YT, Williams L, Zak MJ, Fredericson M. Review of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and a Proposed Scanning Protocol. J Ultrasound Med. 2016 Nov;35(11):2311-2324. doi: 10.7863/ultra.15.12014. Epub 2016 Sep 14.
PubMed 27629754Murciano Casas MP, Rodriguez-Pinero M, Jimenez Sarmiento AS, Alvarez Lopez M, Jimenez Jurado G. Evaluation of ultrasound as diagnostic tool in patients with clinical features suggestive of carpal tunnel syndrome in comparison to nerve conduction studies: Study protocol for a diagnostic testing study. PLoS One. 2023 Nov 10;18(11):e0281221. doi: 10.1371/journal.pone.0281221. eCollection 2023.
PubMed 37948425
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
- ClinicalTrials.gov ID
- NCT05556278
- Acronym / sponsor ID
- RHB-02/2019
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, nerve conduction study, ultrasound, screening, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- 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 main objective is to investigate the value of ultrasound in the diagnosis of Carpal Tunnel Syndrome (CTS), and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values that determine the presence or absence of CTS. Finally, cost-effectiveness analysis is proposed.
Detailed description
The reference test with which the ultrasound is compared is the neurophysiological test (NPT).
The expected timeline for the study is to be performed between July 2020 and May 2023.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Diagnostic Test: Ultrasound study, Diagnostic Test: Neurophysiological testAn electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical suspicion of CTS that come consecutively from the Neurophysiology Department of the Virgen Macarena Hospital in Seville (Spain).
Key inclusion criteria (7 listed)
- Presenting clinical symptoms suggestive of CTS, at least one of the following:
- Age: 18 to 75 years.
- Consent to participate in the study.
Key exclusion criteria (5 listed)
- Previous surgery on the wrist
- Acquired or hereditary pathology causing peripheral neuropathies
- Polyneuropathy of any etiology
- Rheumatoid arthritis
- Diabetes Mellitus
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 |
|---|---|---|
| Ultrasound studybased on the recommendations of the American Association of Electrodiagnostic Medicine (AAEM) (1) | Diagnostic test | Intervention |
| Neurophysiological testAlso: Nerve conduction studyultrasound protocol described by Chen et al. (2) | Diagnostic test | Intervention |
Primary outcome
Demographic variables
Time frame: January 2021 to September 2022
Sex, age, time of evolution of the clinic, manual dominance, hand affected, body mass index, employment status, type of work (pink, white or blue collar), time worked, triggers of symptoms, what symptoms are relieved with, as well as toxic habits, whether they are smokers (to be answered affirmative or negative) or alcohol consumers (to be answered affirmative or negative).
Electrodiagnostic variables
Time frame: January 2021 to September 2022
Motor conduction velocity of the median nerve (calculating distal motor latency and wrist-elbow motor conduction velocity), motor conduction velocity of the ulnar nerve (calculating distal motor latency, lower and upper wrist-elbow motor conduction velocity), orthodromic sensory conduction of the median, ulnar and radial nerve, as well as antidromic sensory conduction of the median, ulnar and radial nerve.
Ultrasound variables
Time frame: January 2021 to September 2022
The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches
Boston Carpal Tunnel Questionnaire
Time frame: January 2021 to September 2022
Cost evaluation
Time frame: From September 2022 to May 2023
Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 12115985American Association of Electrodiagnostic Medicine, American Academy of Neurology, and American Academy of Physical Medicine and Rehabilitation. Practice parameter for electrodiagnostic studies in carpal tunnel syndrome: summary statement. Muscle Nerve. 2002 Jun;25(6):918-22. doi: 10.1002/mus.10185. No abstract available.
- Background: PubMed 27629754Chen YT, Williams L, Zak MJ, Fredericson M. Review of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and a Proposed Scanning Protocol. J Ultrasound Med. 2016 Nov;35(11):2311-2324. doi: 10.7863/ultra.15.12014. Epub 2016 Sep 14.
- Derived from this study: PubMed 37948425Murciano Casas MP, Rodriguez-Pinero M, Jimenez Sarmiento AS, Alvarez Lopez M, Jimenez Jurado G. Evaluation of ultrasound as diagnostic tool in patients with clinical features suggestive of carpal tunnel syndrome in comparison to nerve conduction studies: Study protocol for a diagnostic testing study. PLoS One. 2023 Nov 10;18(11):e0281221. doi: 10.1371/journal.pone.0281221. eCollection 2023.
- Individual participant dataSharing planned: Yes. The full study protocol can be accessed by contacting the trial team at (e-mail). Anonymized participants level data and statistical codes used for the analysis are available on request and subject to data sharing agreements. Data sharing may only be possible after relevant embedded trials have been published.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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 7 inclusion and 5 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 27 Sep 2022. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic variables (time frame: January 2021 to September 2022). The study lists 5 primary outcomes in all. 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 NCT05556278, 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 27 Sep 2022.