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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737239
• Other study ID #: 14552
• Status: Recruiting
• Start date: December 23, 2020
• Est. completion date: December 22, 2024

Study information

• Verified date: November 2023
• Source: Henry Ford Health System
• Contact: Elizabeth A Washnock-Schmid, B.S.
• Phone: 8103474715
• Email: gn3092[@]wayne.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Other:
• Corticosteroid injections for CTS treatment
Treatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpel Tunnel Questionnaire	Scaled 1-5, higher scores indicate worse outcomes	Dec 23 2020-Dec 22 2021
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	2-point discrimination Test	Scaled 2-8mm, higher scores indicate worse outcomes	Dec 23 2020-Dec 22 2021
Secondary	QuickDash score	Scaled 1-100, higher scores indicate worse outcomes	Dec 23 2020-Dec 22 2021
Secondary	Grip Strength score	Scored in pounds(lbs), higher scores indicate better outcomes	Dec 23 2020-Dec 22 2021