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

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

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 Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Corticosteroid injections for CTS treatment

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Elizabeth A Washnock-Schmid, B.S.; Phone Number: 8103474715; Email: gn3092@wayne.edu
• Study Contact Backup: Name: Aaron R Prater, M.S.; Phone Number: 2692752828; Email: aprater1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Contact: Charles S Day, M.D., M.B.A.; Phone Number: 313-916-5846; Email: cday9@hfhs.org
      • Contact: Elizabeth A Washnock-Schmid, B.S.; Phone Number: 8103474714; Email: gn3092@wayne.edu
      • Principal Investigator: Charles S Day, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients clinically diagnosed with CTS, have a negative or mild EMG study, and receive a corticosteroid injection at Henry Ford Health System Orthopedics.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with CTS/Mild EMG	Other: Corticosteroid injections for CTS treatment; Treatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients
Patient with CTS/Negative EMG	Other: Corticosteroid injections for CTS treatment; Treatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpel Tunnel Questionnaire	Scaled 1-5, higher scores indicate worse outcomes	Dec 23 2020-Dec 22 2021

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Publications and helpful links

General Publications

• Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
• Graham B, Regehr G, Naglie G, Wright JG. Development and validation of diagnostic criteria for carpal tunnel syndrome. J Hand Surg Am. 2006 Jul-Aug;31(6):919-24.
• Visser LH, Ngo Q, Groeneweg SJ, Brekelmans G. Long term effect of local corticosteroid injection for carpal tunnel syndrome: a relation with electrodiagnostic severity. Clin Neurophysiol. 2012 Apr;123(4):838-41. doi: 10.1016/j.clinph.2011.08.022. Epub 2011 Oct 1.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Estimated): March 22, 2024
• Study Completion (Estimated): December 22, 2024

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: electromyography; corticosteroid injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 14552 (University of California, San Francisco)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No