Carpal Tunnel Syndrome (CTS)NCT06766370
The Application of Multimodal Ultrasound Imaging in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The aim of this study is to explore the application value of multimodal ultrasound parameters in the diagnosis and treatment follow-up of Carpal Tunnel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Ultrasound-guided nerve hydrodissection treatment
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: This study primarily utilizes ultrasound multimodal imaging to observe the changes in multiple parameter indicators before and after the treatment of nerve hydrodissection combined with transverse carpal ligament release in patients clinically diagnosed with mild to moderate Carpal Tunnel Syndrome.
Who may be able to join
- Age between 18 and 70 years;
- Presence of sensory abnormalities and motor dysfunction in the median nerve distribution area;
- Positive Tinel's sign or Phalen's test;
- Neurophysiological examination consistent with mild to moderate Carpal Tunnel Syndrome.-
Who cannot join
- Severe Carpal Tunnel Syndrome;
- Concurrent rheumatic, metabolic, systemic, or other systemic diseases;
- Concurrent cervical spondylosis or other peripheral neuropathies;
- Wrist joint trauma, surgery, space-occupying lesions, or nerve itself with space-occupying lesions;
- Concurrent malignant tumors or severe cardiopulmonary diseases;
- History of previous wrist surgery or injections;
- Pregnancy;
- Allergy to corticosteroids or local anesthetics.-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to explore the application value of multimodal ultrasound parameters in the diagnosis and treatment follow-up of Carpal Tunnel Syndrome.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Ultrasound-guided nerve hydrodissection treatment
- Keywords
- 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.
Ultrasound-guided nerve hydrodissection treatmentProcedure or surgery
Under ultrasound guidance, a mixed solution of corticosteroids and local anesthetics is injected around the nerve, followed by release of the transverse carpal ligament.
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire ，BCTQ
The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult.The higher scores mean a worse outcome.
Measured: 1,3,6,12 months
Secondary outcomes (2)
the patient's sensory nerve conduction velocity (SNCV)
SNCV in m/s
Measured: 3,6,12months
the patient's distal motor latency (DML).
DML in ms
Measured: 3,6,12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. weijing zhang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766370
- Sponsor's protocol ID
- 2024-796-01
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Multimodal Ultrasound Imaging in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06766370
- Acronym / sponsor ID
- 2024-796-01
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 Jan 2025 (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 aim of this study is to explore the application value of multimodal ultrasound parameters in the diagnosis and treatment follow-up of Carpal Tunnel Syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study primarily utilizes ultrasound multimodal imaging to observe the changes in multiple parameter indicators before and after the treatment of nerve hydrodissection combined with transverse carpal ligament release in patients clinically diagnosed with mild to moderate Carpal Tunnel Syndrome.
Key inclusion criteria (4 listed)
- Age between 18 and 70 years;
- Presence of sensory abnormalities and motor dysfunction in the median nerve distribution area;
- Positive Tinel's sign or Phalen's test;
- Neurophysiological examination consistent with mild to moderate Carpal Tunnel Syndrome.-
Key exclusion criteria (8 listed)
- Severe Carpal Tunnel Syndrome;
- Concurrent rheumatic, metabolic, systemic, or other systemic diseases;
- Concurrent cervical spondylosis or other peripheral neuropathies;
- Wrist joint trauma, surgery, space-occupying lesions, or nerve itself with space-occupying lesions;
- Concurrent malignant tumors or severe cardiopulmonary diseases;
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-guided nerve hydrodissection treatmentUnder ultrasound guidance, a mixed solution of corticosteroids and local anesthetics is injected around the nerve, followed by release of the transverse carpal ligament. | Procedure or surgery | – |
Primary outcome
Boston Carpal Tunnel Syndrome Questionnaire ，BCTQ
Time frame: 1,3,6,12 months
The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult.The higher scores mean a worse outcome.
2 secondary outcomes
the patient's sensory nerve conduction velocity (SNCV)
Time frame: 3,6,12months
the patient's distal motor latency (DML).
Time frame: 3,6,12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 8 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: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanjing Trum Tower Hospital (15651890325, weijing_zhang@163.com), 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 ，BCTQ (time frame: 1,3,6,12 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 9 Jan 2025.