Carpal Tunnel SyndromeNCT04737239
Corticosteroid Injection Effectiveness in Carpel Tunnel Patients With Negative or Mild EMG Studies
An observational study of Carpal Tunnel Syndrome, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Corticosteroid injections for CTS treatment
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 22 Mar 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Corticosteroid injections for CTS treatment
- Keywords
- corticosteroid injection, electromyography
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injections for CTS treatmentOther
Treatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients
| Study group | Role | What they receive |
|---|---|---|
| Patient with CTS/Mild EMG | Not described Receives: Other: Corticosteroid injections for CTS treatment | |
| Patient with CTS/Negative EMG | Not described Receives: Other: Corticosteroid injections for CTS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpel Tunnel Questionnaire
Scaled 1-5, higher scores indicate worse outcomes
Measured: Dec 23 2020-Dec 22 2021
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Dec 23 2020-Dec 22 2021
2-point discrimination Test
Scaled 2-8mm, higher scores indicate worse outcomes
Measured: Dec 23 2020-Dec 22 2021
QuickDash score
Scaled 1-100, higher scores indicate worse outcomes
Measured: Dec 23 2020-Dec 22 2021
Grip Strength score
Scored in pounds(lbs), higher scores indicate better outcomes
Measured: Dec 23 2020-Dec 22 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start23 Dec 2020
- Primary completion22 Mar 2026
- Study completion22 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles S Day, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737239
- Sponsor's protocol ID
- 14552
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2021
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27751557Graham 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.
PubMed 16886290Visser 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.
PubMed 21962473
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Injection Effectiveness in Carpel Tunnel Patients With Negative or Mild EMG
- ClinicalTrials.gov ID
- NCT04737239
- Acronym / sponsor ID
- 14552
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- corticosteroid injection, electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 22 Mar 2026 (actual)
- Study completion
- 22 Mar 2026 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with CTS/Mild EMG | – | Other: Corticosteroid injections for CTS treatment |
| Patient with CTS/Negative EMG | – | Other: Corticosteroid injections for CTS treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid injections for CTS treatmentTreatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients | Other | Patient with CTS/Mild EMG, Patient with CTS/Negative EMG |
Primary outcome
Boston Carpel Tunnel Questionnaire
Time frame: Dec 23 2020-Dec 22 2021
Scaled 1-5, higher scores indicate worse outcomes
7 secondary outcomes
Number of patients with numbness in the median n. distribution
Time frame: Dec 23 2020-Dec 22 2021
Number of patients with weakness/atrophy of the thenar musculature
Time frame: Dec 23 2020-Dec 22 2021
Number of patients with positive Tinel's Sign
Time frame: Dec 23 2020-Dec 22 2021
Number of patients with positive Phalen's Test
Time frame: Dec 23 2020-Dec 22 2021
2-point discrimination Test
Time frame: Dec 23 2020-Dec 22 2021
QuickDash score
Time frame: Dec 23 2020-Dec 22 2021
Grip Strength score
Time frame: Dec 23 2020-Dec 22 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 27751557Padua 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.
- Background: PubMed 16886290Graham 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.
- Background: PubMed 21962473Visser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpel Tunnel Questionnaire (time frame: Dec 23 2020-Dec 22 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737239, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.