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

NCT ID: NCT04737239

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-23

Study Completion Date

2024-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with CTS/Mild EMG

Corticosteroid injections for CTS treatment

Intervention Type OTHER

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

Patient with CTS/Negative EMG

Corticosteroid injections for CTS treatment

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Corticosteroid injections for CTS treatment

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charles S Day

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elizabeth A Washnock-Schmid, B.S.

Role: CONTACT

8103474715

Aaron R Prater, M.S.

Role: CONTACT

2692752828

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Charles S Day, M.D., M.B.A.

Role: primary

313-916-5846

Elizabeth A Washnock-Schmid, B.S.

Role: backup

8103474714

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27751557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16886290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21962473 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14552

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acupuncture for Carpal Tunnel Syndrome
NCT00000394 COMPLETED PHASE2