A Comparison of Ultrasound-guided Steroid Injection With Wrist Splint in Carpal Tunnel Syndrome

Status unconfirmed · Phase 4

Conditions studied: Carpal Tunnel Syndrome

In brief

Carpal Tunnel Syndrome (CTS) is caused by compression of a nerve called the median nerve as it travels through a narrow tunnel within the wrist on its way to the hand. Compression of the median nerve causes numbness, tingling, pain and weakness of the hand and fingers. CTS is usually treated with rest or a change in the activity level. It can also be treated with a splint that limits bending of the hand and wrist. Other treatments include a steroid injection near the median nerve. Surgery can be performed if the symptoms are severe or persistent. Compression of the median nerve can cause swelling that may be observed with ultrasound of the wrist. Ultrasound can also be used to help guide the needle to inject the steroid solution in close proximity to the median nerve while avoiding injury to the nerve. The investigators plan to compare the effectiveness of a splint and an ultrasound-guided steroid injection in the treatment of mild to moderate CTS. Individuals with CTS who agree to participate, will be randomly assigned to two groups. One group will be treated with a splint and the other with a steroid injection performed under ultrasound guidance. The severity of CTS symptoms will be determined prior to beginning the study and also at 6 weeks, 3 months, 6 months and 1 year following each of the two treatment interventions. The median nerve size (diameter) will be measured in all participants prior to beginning the study and also following both treatment interventions at 6 weeks, 3 months, 6 months and 1 year. At the conclusion of the study, the investigators will determine which of the two treatments, splint or steroid injection, is more effective in alleviating CTS symptoms. The investigators will also determine if either or both treatments result in a change in swelling of the median nerve as measured by ultrasound.

Key facts

Study ID

NCT04515966

Run by

Mercy Health Ohio

People needed

70

Starts

2020-12-01

Expected to finish

2022-11-01

Last updated by the study team

2021-09-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with typical symptoms of CTS, including nocturnal, postural, or usage-associated paresthesia of the hand
• symptoms persisting for at least 3 months before the study
• Patients with mild to moderate symptoms
• no history of steroid injections in the past
• no history of CT release surgery
• and age 18 to 75.

You may not qualify if…

• Thenar atrophy or muscle weakness
• severe CTS
• pregnancy
• hypothyroidism
• diabetes mellitus
• chronic renal failure
• rheumatoid arthritis
• orthopedic or neurological disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
• history of distal radius fracture
• anticoagulation
• chronic use of systemic corticosteroids
• known allergy to corticosteroids and local anesthetics.

Where it is running

• St. Elizabeth Boardman Family Medicine — Boardman, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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