Recruiting

Steroid Injection vs. Splint

Sponsor:

Mercy Health Ohio

Code:

NCT04515966

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone Injection [Solu-Medrol]

wrist splint

Study Details

Brief summary:

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT04515966

Start date

Dec 1, 2020

Status verified date

Sep, 2021

Completion date

Nov 1, 2022

Anticipated

Primary completion date

Jun 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ultrasound-guided steroid injection

Participants with CTS who meet the inclusion criteria are randomized to two groups. One group (or arm) will receive an ultrasound-guided steroid injection in the vicinity of the median nerve within the carpal tunnel. A total 1 ml of injectate consisting of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine is injected into the carpal tunnel under ultrasound guidance to deliver it into the target area. After completion of the injection, the distal carpal tunnel is scanned to ensure injectate distribution within the distal aspect of the carpal tunnel.

active comparator: Wrist splint

Participants in this arm are treated with a wrist splint.

Interventions

Methylprednisolone Injection [Solu-Medrol]

A total 1 ml of injectate consisting of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine will be injected into the carpal tunnel under ultrasound guidance to deliver it into the target area. After completion of the injection, the distal carpal tunnel is scanned to ensure injectate distribution within the distal aspect of the carpal tunnel.

wrist splint

A standard wrist splint

Primary outcome measure

  • Carpal tunnel syndrome, Change in symptom severity from baseline to 6 weeks [ Time Frame: Baseline, 6 weeks ]
  • Carpal tunnel syndrome, Change in functional status from baseline to 6 weeks [ Time Frame: Baseline, 6 weeks ]
  • Carpal tunnel syndrome, Change in pain assessment from baseline to 6 weeks [ Time Frame: Baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Roy N. Morcos, M.D.

(330)729-8700roy_morcos@mercy.com

Locations

St. Elizabeth Boardman Family Medicine

Recruiting

Boardman, Ohio, United States, 44512

More Information

Sponsor

Mercy Health Ohio

Last update posted

Sep 9, 2021

Last verified

Sep, 2021

Keywords

  • wrist splint
  • steroid injection
  • median nerve ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Health Ohio on 2021-09-09.