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

NCT04737239 | Completed

• 1 other identifier: 14552
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

corticosteroid injection; electromyography

Outcome Measures

Primary Outcomes (1)

• Boston Carpel Tunnel Questionnaire

  Scaled 1-5, higher scores indicate worse outcomes

  Dec 23 2020-Dec 22 2021

Secondary Outcomes (7)

• 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

• Number of patients with positive Phalen's Test

  Dec 23 2020-Dec 22 2021

• 2-point discrimination Test

  Dec 23 2020-Dec 22 2021

Study Arms (2)

Patient with CTS/Mild EMG

Other: Corticosteroid injections for CTS treatment

Patient with CTS/Negative EMG

Other: Corticosteroid injections for CTS treatment

Interventions

Corticosteroid injections for CTS treatment OTHER

Treatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients

Patient with CTS/Mild EMG; Patient with CTS/Negative EMG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

• 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.

  PMID: 27751557 BACKGROUND

• 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.

  PMID: 16886290 BACKGROUND

• 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.

  PMID: 21962473 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 3, 2021
• Study Start: December 23, 2020
• Primary Completion: March 22, 2026
• Study Completion: March 22, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

US (1)