The Application of Multimodal Ultrasound Imaging in Carpal Tunnel Syndrome

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 Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Procedure: Ultrasound-guided nerve hydrodissection treatment

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Nanjing Trum Tower Hospital; Phone Number: 15651890325; Email: weijing_zhang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

1. Age between 18 and 70 years;
2. Presence of sensory abnormalities and motor dysfunction in the median nerve distribution area;
3. Positive Tinel's sign or Phalen's test;
4. Neurophysiological examination consistent with mild to moderate Carpal Tunnel Syndrome.-

Exclusion Criteria:

1. Severe Carpal Tunnel Syndrome;
2. Concurrent rheumatic, metabolic, systemic, or other systemic diseases;
3. Concurrent cervical spondylosis or other peripheral neuropathies;
4. Wrist joint trauma, surgery, space-occupying lesions, or nerve itself with space-occupying lesions;
5. Concurrent malignant tumors or severe cardiopulmonary diseases;
6. History of previous wrist surgery or injections;
7. Pregnancy;
8. Allergy to corticosteroids or local anesthetics.-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1,3,6,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the patient's sensory nerve conduction velocity (SNCV)	SNCV in m/s	3,6,12months
the patient's distal motor latency (DML).	DML in ms	3,6,12months

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 2024-796-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No