Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Carpal tunnel syndrome, Change in symptom severity from baseline to 6 weeks
Study Overview
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.
Detailed Description
The purpose of the study is to determine which of two commonly used therapeutic interventions for the treatment of carpal tunnel syndrome (CTS), steroid injection or wrist splint, is more effective in alleviating symptoms. The protocol has been approved by the Medical Research Committee and by the Institutional Review Board, Mercy Health, Youngstown.
The steroid injection will be administered under ultrasound guidance to ensure proper placement of the needle in close proximity to the median nerve within the carpal tunnel and to minimize the risk of direct trauma to the nerve.
Candidates for the study will be individuals with CTS presenting to primary care offices located in the Boardman, Ohio area. Following a detailed explanation of the study purpose and protocol, those individuals who agree to participate will be asked to sign an informed consent form.
A complete history and physical examination will be performed on all participants to confirm the diagnosis. Additionally, baseline ultrasound measurement of the median nerve cross-sectional area within the carpal tunnel will be performed on all participants. The diagnosis of CTS will be made on clinical grounds, and the CTS-6 evaluation tool will also be used in the diagnostic evaluation. A score above 12 will be considered consistent with CTS. Participants with moderately severe CTS will undergo a nerve conduction study to confirm the diagnosis and exclude early signs of denervation which may require surgical decompression.
Participants will be randomized into two groups of thirty-five patients each; those in group A will undergo ultrasound-guided steroid injection and those in group B will be asked to wear a standard carpal tunnel splint. Participants will be randomly assigned to either intervention group with the use of a computer-generated random sequence of numbers from 1 to 70. The primary investigator (Roy Morcos) will be responsible for maintaining confidential records in a secure location.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Methylprednisolone Injection [Solu-Medrol] (Drug)
Wrist splint
Participants in this arm are treated with a wrist splint.
Intervention: wrist splint (Device)
Outcomes
Primary Outcomes
Carpal tunnel syndrome, Change in symptom severity from baseline to 6 weeks
Time Frame: Baseline, 6 weeks
Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS). 11 questions with score ranging from 1 (Normal) to 5 (Very Serious). Composite score range 11-55. The score mapping is as follows: 11: Asymptomatic; 12 to 22: Mild; 23 to 33: Moderate; 34 to 44: Severe; 45-55: Very Severe. Questionnaire is administered by an investigator.
Carpal tunnel syndrome, Change in pain assessment from baseline to 6 weeks
Time Frame: Baseline, 6 weeks
Visual Analog Scale (VAS). A visual pain scale measures a patient's pain intensity. Scale ranging from 0 (No Pain) to 10 (Unbearable Pain) characterized by depictions of facial expressions. The score mapping is as follows: 0: No Pain; 1 to 3: Mild Pain; 4 to 6: Moderate Pain; 7 to 10: Severe Pain Assessment is performed by an investigator.
Carpal tunnel syndrome, Change in functional status from baseline to 6 weeks
Time Frame: Baseline, 6 weeks
Boston Carpal Tunnel Questionnaire (BCTQ) Functional Status Scale (FSS). 8 questions with score ranging from 1 (No Difficulty) to 5 (Unable to Perform). Composite score range 8-40. The score mapping is as follows: 8: Asymptomatic; 9 to 16: Mild; 17 to 24: Moderate; 25 to 32: Severe; 33-40: Very Severe. Questionnaire is administered by an investigator.
Secondary Outcomes
- Carpal tunnel syndrome, Change in symptom severity at 12 weeks, 6 months, 1 year(12 weeks, 6 months, 1 year)
- Change in Median Nerve Dimensions(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Carpal tunnel syndrome, Change in functional status at 12 weeks, 6 months, 1 year(12 weeks, 6 months, 1 year)
- Carpal tunnel syndrome, Change in pain perception at 12 weeks, 6 months, 1 year(12 weeks, 6 months, 1 year)
Investigators
Roy Morcos
Professor, Family and Community Medicine
Mercy Health Ohio