Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to learn if researchers can identify through ultrasound images and clinical assessment which subjects with carpel tunnel syndrome will do better following standard of care non-surgical or surgical treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-surgical treatment | When clinically indicated, subjects will receive a standard of care carpal tunnel injection whose volume and specific steroid drug will be based on the recommendation of the treating clinician |
| |
| Surgical treatment | When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid Injection | Drug | volume and specific steroid drug will be based on the recommendation of the treating clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CTSAQ symptom score | A change from baseline scores will be used to assess outcome | Baseline - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hand/wrist pain by VAS | A change from baseline will be used to assess outcome | Baseline - 12 month |
| Change in CTSAQ function score | A change from baseline will be used to assess outcome |
Not provided
The following criteria must be answered yes to be enrolled:
EXCLUSION CRITERIA The following questions if answered yes will exclude the patient from participation in the study.
Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand?
Does the patient have a known tumor, mass or deformity of the study hand or wrist?
Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)?
Does the patient have any of the following diagnoses or conditions:
Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?
Not provided
Not provided
Subjects will be identified among those presenting to the Hand Clinic with a referral diagnosis of CTS, and from those referred for EDS with a referral diagnosis of CTS, who are clinically indicated for either a steroid injection or surgery. Those who meet these and the inclusion criteria, do not meet the exclusion criteria, and who consent to participate will be entered in the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Amadio, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013256 | Steroids |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| Carpel Tunnel surgery | Procedure | Standard of care carpel tunnel surgery |
|
| Baseline - 12 month |
| Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring | CES-D questionnaire scoring will be used to assess outcomes | Baseline - 12 month |