NCT06766370

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Feb 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Feb 2025Dec 2028

First Submitted

Initial submission to the registry

December 22, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

December 22, 2024

Last Update Submit

January 4, 2025

Conditions

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the patient's sensory nerve conduction velocity (SNCV)

    3,6,12months

  • the patient's distal motor latency (DML).

    3,6,12months

Interventions

Under ultrasound guidance, a mixed solution of corticosteroids and local anesthetics is injected around the nerve, followed by release of the transverse carpal ligament.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.-

You may not qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Central Study Contacts

Nanjing Trum Tower Hospital

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 9, 2025

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2028

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share