Clinical trial NCT04737239: Corticosteroid Injection Effectiveness in Carpel Tunnel Patients With Negative or Mild EMG Studies
Official title: Corticosteroid Injection Effectiveness in Carpel Tunnel Patients With Negative or Mild EMG
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Keywords: corticosteroid injection
electromyography
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Boston Carpel Tunnel Questionnaire
timeFrame: Dec 23 2020-Dec 22 2021
Secondary outcomes:
measure: Number of patients with numbness in the median n. distribution
timeFrame: Dec 23 2020-Dec 22 2021
measure: Number of patients with weakness/atrophy of the thenar musculature
timeFrame: Dec 23 2020-Dec 22 2021
measure: Number of patients with positive Tinel's Sign
timeFrame: Dec 23 2020-Dec 22 2021
measure: Number of patients with positive Phalen's Test
timeFrame: Dec 23 2020-Dec 22 2021
measure: 2-point discrimination Test
timeFrame: Dec 23 2020-Dec 22 2021
measure: QuickDash score
timeFrame: Dec 23 2020-Dec 22 2021
measure: Grip Strength score
timeFrame: Dec 23 2020-Dec 22 2021
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
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.
citation: 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.
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.