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

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Corticosteroid injections for CTS treatment

• Registration Number: NCT04737239
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-03-22
• Study Completion: 2024-12-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with CTS/Mild EMG	Corticosteroid injections for CTS treatment	-
Patient with CTS/Negative EMG	Corticosteroid injections for CTS treatment	-

Primary Outcome Measures

Name	Time	Method
Boston Carpel Tunnel Questionnaire	Dec 23 2020-Dec 22 2021	Scaled 1-5, higher scores indicate worse outcomes

Secondary Outcome Measures

Name	Time	Method
Number of patients with weakness/atrophy of the thenar musculature	Dec 23 2020-Dec 22 2021	Positive test includes weakness in grip or holding objects as described by participant, assessed by physician
Number of patients with positive Tinel's Sign	Dec 23 2020-Dec 22 2021	Positive sign includes 'pins and needles' in parts of palm, thumb, second and third finger upon percussion of median nerve, assessed by physician
Number of patients with positive Phalen's Test	Dec 23 2020-Dec 22 2021	Positive test includes pain in parts of palm, thumb, second and third finger associated with compression of the median nerve, assessed by physician
QuickDash score	Dec 23 2020-Dec 22 2021	Scaled 1-100, higher scores indicate worse outcomes
Grip Strength score	Dec 23 2020-Dec 22 2021	Scored in pounds(lbs), higher scores indicate better outcomes
Number of patients with numbness in the median n. distribution	Dec 23 2020-Dec 22 2021	Positive test includes numbness in parts of palm, thumb, second and third finger, assessed by physician
2-point discrimination Test	Dec 23 2020-Dec 22 2021	Scaled 2-8mm, higher scores indicate worse outcomes

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States