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Hydrodissection as a Treatment for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03427983
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Peter C. Amadio, M.D., Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Hydrodissection Procedure: Regular Injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Actual Study Start Date : March 8, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019


Arm Intervention/treatment
US-guided regular injection
US in-plane injection with corticosteroid and 1cc of lidocaine. Total of 2cc.
Procedure: Regular Injection
Corticosteroid and lidocaine injection without additional saline is used as routine treatment.

US-guided hydrodissection
US in-plane injection with corticosteroid and 1cc of lidocaine, and 3cc of saline. Total of 5cc.
Procedure: Hydrodissection
Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.




Primary Outcome Measures :
  1. Tolerance [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Clinical Severity of Carpal Tunnel Syndrome [ Time Frame: 6 months ]
    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.

  2. Overall Pain [ Time Frame: 6 months ]
    The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale.

  3. Additional Treatment [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427983


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Peter C Amadio, MD Mayo Clinic

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Responsible Party: Peter C. Amadio, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03427983     History of Changes
Other Study ID Numbers: 17-009840
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action