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Clinical Trials/NCT04737239
NCT04737239CompletedNot Applicable

Corticosteroid Injection Effectiveness in Carpel Tunnel Patients With Negative or Mild EMG

Henry Ford Health System1 site in 1 country61 target enrollmentStarted: December 23, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
1
Primary Endpoint
Boston Carpel Tunnel Questionnaire

Study Overview

Brief Summary

Carpal Tunnel Syndrome (CTS) is the most common nerve entrapment syndrome worldwide. There are currently no studies examining the effectiveness of corticosteroid injections in patients with normal (negative) EMG studies. The purpose of this study is to gain a better understanding of the duration of symptom improvement post corticosteroid injection in patients with negative or mild EMG studies. The Boston Carpal Tunnel Questionnaire will be given to patients undergoing corticosteroid injections for the treatment of carpal tunnel syndrome to assess their response to the injection. Investigators will collect data retrospectively. The Boston Carpal Tunnel Questionnaire (BCTQ) is administered as per standard protocol to all patients with CTS who have a negative or mild EMG study. The BCTQ assesses the patient's self-reported symptom severity and functional status. Investigators will analyze this data with respect to demographics as well as numbness in the median n. distribution, nocturnal numbness, weakness/atrophy of the thenar musculature, Tinel's sign, Phalen's test, loss of 2-point discrimination, Quick-Dash score, and grip strength score.

The primary outcome will be the Boston Carpal Tunnel Questionnaire outcome score under the different EMG conditions.The secondary outcomes will be numbness in the median n. distribution, nocturnal numbness, weakness/atrophy of the thenar musculature, Tinel's sign, Phalen's test, loss of 2-point discrimination, QuickDash score, and grip strength score. Both outcomes will be examined in patients with negative or mild EMG readings. This information will allow orthopedic physicians to gain a better understanding of the duration of symptom improvement post-corticosteroid injection, allowing them to fine tune their treatment plans for CTS patients.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who speak English
  • •Patients who are 18 years or older
  • •Patients who are clinically diagnosed with CTS
  • •Patients who have a negative or mild EMG study
  • •Patients who receive a corticosteroid injection after obtaining a negative or mild EMG study

Exclusion Criteria

  • •Patients who do not speak English
  • •Patients who are younger than 18 years of age
  • •Patients who have experienced previous trauma to the wrist
  • •Patients who have had previous treatment for CTS including but not limited to corticosteroid injection or surgery
  • •Patients with a moderate or severe EMG study

Arms & Interventions

Patient with CTS/Mild EMG

Intervention: Corticosteroid injections for CTS treatment (Other)

Patient with CTS/Negative EMG

Intervention: Corticosteroid injections for CTS treatment (Other)

Outcomes

Primary Outcomes

Boston Carpel Tunnel Questionnaire

Time Frame: Dec 23 2020-Dec 22 2021

Scaled 1-5, higher scores indicate worse outcomes

Secondary Outcomes

  • Number of patients with positive Phalen's Test(Dec 23 2020-Dec 22 2021)
  • Number of patients with numbness in the median n. distribution(Dec 23 2020-Dec 22 2021)
  • Number of patients with weakness/atrophy of the thenar musculature(Dec 23 2020-Dec 22 2021)
  • Number of patients with positive Tinel's Sign(Dec 23 2020-Dec 22 2021)
  • QuickDash score(Dec 23 2020-Dec 22 2021)
  • Grip Strength score(Dec 23 2020-Dec 22 2021)
  • 2-point discrimination Test(Dec 23 2020-Dec 22 2021)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charles S Day

Orthopedic Surgeon

Henry Ford Health System

Study Sites (1)

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