Hydrodissection as a Treatment for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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This is a pilot study designed to acquire data on the added value of hydrodissection when using a corticosteroid injection as a treatment for patients with carpal tunnel syndrome. Hydrodissection is part of a standard clinical care injection under ultrasound guidance in which the fluid is used to separate the nerve from surrounding structures.

Official Title
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Hydrodissection as a Treatment for Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Hydrodissection
* Procedure: Regular Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical CTS diagnosis with indication for steroid injection as determined by attending physician (if both hands are involved, only the side with the most severe CTS as indicated by electromyography (EMG) will be included) AND adult men and women between age 21 and 80 AND no more than moderate severity as indicated by EMG AND symptoms of numbness or tingling for at least 4 weeks in the median nerve distribution area AND classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram AND ability to complete English-language questionnaires and clinical evaluations AND is reachable by phone for the follow up contact Exclusion Criteria: Exclusion criteria are largely based on the premises of only including patients with idiopathic carpal tunnel syndrome without expected interferences of the acquisition of the ultrasound images or corticosteroid treatment. Previous Carpal Tunnel Release (CTR) or other volar wrist surgery on the study hand OR known tumor/mass OR deformity of the study hand/wrist OR previous history of steroid injection into carpal tunnel OR currently taking a steroid medication either regularly or on an as needed basis OR any of the following clinical diagnoses or conditions: Cervical radiculopathy; rheumatoid or other inflammatory arthritis, including gout; osteoarthritis in the wrist; renal failure; sarcoidosis; peripheral nerve disease; diabetes, thyroid disease or other metabolic disorder; pregnancy; amyloidosis; or major trauma (fractures or complete ligamentous tears) to the ipsilateral arm OR prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized blinded study looking at two different ways of drug administration rather than the drug itself. We will compare ultrasound guided injection with hydrodissection to ultrasound guided injection without hydrodissection. In both groups, the active drug is the same in type and amount.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: US-guided regular injection<br>US in-plane injection with corticosteroid and 1cc of lidocaine. Total of 2cc. | Procedure: Regular Injection<br>* Corticosteroid and lidocaine injection without additional saline is used as routine treatment.<br>|
| Other: US-guided hydrodissection<br>US in-plane injection with corticosteroid and 1cc of lidocaine, and 3cc of saline. Total of 5cc. | Procedure: Hydrodissection<br>* Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Acquire data on the added value of hydrodissection when using injection as a treatment for patients with Carpal Tunnel Syndrome (CTS). Questionnaires will be used to assess level of tolerance using a 10 point Likert Scale. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Severity of Carpal Tunnel Syndrome | The Boston Carpal Tunnel Assessment questionnaire will be used to assess both symptom severity and functional status using a 19 item questionnaire with scores between values 1-5. | 6 months | 
| Overall Pain | The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale. | 6 months | 
| Additional Treatment | After 6 months patients will be asked whether they have had additional treatment for their Carpal Tunnel Syndrome after the ultrasound guided injection. The date, location, and time frame of the additional treatment will be recorded. | 6 months |