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

Carpal Tunnel Syndrome Clinical Trial

Official title:

Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515966
• Other study ID #: 20-006
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2021
• Source: Mercy Health Ohio
• Contact: Roy N. Morcos, M.D.
• Phone: (330)729-8700
• Email: roy_morcos[@]mercy.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

The injections will be performed by Dr. Morcos and Dr. Dhungana. Dr. Morcos received training in ultrasonography during a fellowship program and has published on the subject. He has been performing ultrasound examinations and injections for the past 35 years. Dr. Dhungana is an orthopedic surgeon with expertise in carpal tunnel steroid injections.

With the participant seated and the forearm supinated, the wrist is slightly dorsiflexed. The median nerve is identified with real-time ultrasonography and its cross-sectional area measured. Injection near the median nerve within the carpal tunnel is performed under aseptic technique and ultrasound guidance, using a 25-gauge needle to minimize discomfort.

Group A: A mixture 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 in close proximity to the median nerve. After completion of the injection, the distal carpal tunnel is scanned to ensure even injectate distribution within the distal aspect of the carpal tunnel.

Group B: Patients in this group will be advised to wear a standard carpal tunnel splint with the hand in neutral position. The splint will be provided to all participants. They will be advised to wear it during the night and most of the time during day.

The median nerve cross-sectional area is measured in all patients at baseline, 6 weeks and 3 months following interventions.

Follow-up is scheduled 6 weeks, 3 months, 6 months and one year. At each follow-up visit, clinical evaluation is obtained using the BCTQ score, which determines the degree of symptomatic severity and functional recovery. A visual analog scale (VAS) for pain, 0 for no pain and 10 for severe unbearable pain, will also be obtained. Follow-up will continue for a year including history and physical examination.

Descriptive statistics will be used to characterize the data using the mean, standard deviation, and median. For parameter with subset scales and values, box and whisker plots will be used to show patterns of parameter behavior. Where levels of measures are appropriate, independent samples t-tests are performed to compare outcomes of each intervention. Where appropriate, a non-parametric test such as the Mann-Whitney U test, is used to assess differences of parameter values both over periods of follow up and between two treatments.

The measures of effect are as follows: Pain, Symptom severity, Functional disability, Median nerve diameter, Median nerve cross sectional area. Three of the parameters are from arbitrary scales consisting of standard questionnaires. Two of the parameters are composite values derived from scores with differing weightings. Two anatomic measures are based on metric measurements obtained by ultrasound. All measures will be taken before treatment and at 6 weeks, 12 weeks, 6 months and 1 year. Based on an assumed BCTS Pain Score treatment effect of 1.5 with standard deviation of 3.0 with 2-sided α of 0.05 and a power of 0.87, the minimum required sample size in each study group is 32. Considering loss to follow-up over a period of one year, the investigators plan to recruit 70 subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• 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.

Device:
• wrist splint
A standard wrist splint

Locations

Country	Name	City	State
United States	St. Elizabeth Boardman Family Medicine	Boardman	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Health Ohio

Country where clinical trial is conducted

United States, 

References & Publications (13)

Calandruccio JH, Thompson NB. Carpal Tunnel Syndrome: Making Evidence-Based Treatment Decisions. Orthop Clin North Am. 2018 Apr;49(2):223-229. doi: 10.1016/j.ocl.2017.11.009. Epub 2018 Feb 1. Review. — View Citation

Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1. — View Citation

Demircay E, Civelek E, Cansever T, Kabatas S, Yilmaz C. Anatomic variations of the median nerve in the carpal tunnel: a brief review of the literature. Turk Neurosurg. 2011;21(3):388-96. doi: 10.5137/1019-5149.JTN.3073-10.1. Review. — View Citation

Evers S, Bryan AJ, Sanders TL, Selles RW, Gelfman R, Amadio PC. Effectiveness of Ultrasound-Guided Compared to Blind Steroid Injections in the Treatment of Carpal Tunnel Syndrome. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1060-1065. doi: 10.1002/acr.23108. Epub 2017 Jun 8. — View Citation

Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8. — View Citation

Karadas Ö, Tok F, Akarsu S, Tekin L, Balaban B. Triamcinolone acetonide vs procaine hydrochloride injection in the management of carpal tunnel syndrome: randomized placebo-controlled study. J Rehabil Med. 2012 Jun;44(7):601-4. doi: 10.2340/16501977-0990. — View Citation

Khosrawi S, Emadi M, Mahmoodian AE. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial. Adv Biomed Res. 2016 Feb 8;5:16. doi: 10.4103/2277-9175.175902. eCollection 2016. — View Citation

Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5. Review. — View Citation

Klauser AS, Halpern EJ, Faschingbauer R, Guerra F, Martinoli C, Gabl MF, Arora R, Bauer T, Sojer M, Löscher WN, Jaschke WR. Bifid median nerve in carpal tunnel syndrome: assessment with US cross-sectional area measurement. Radiology. 2011 Jun;259(3):808-15. doi: 10.1148/radiol.11101644. Epub 2011 Mar 8. — View Citation

Middleton SD, Anakwe RE. Carpal tunnel syndrome. BMJ. 2014 Nov 6;349:g6437. doi: 10.1136/bmj.g6437. Review. — View Citation

Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11. Review. — View Citation

So H, Chung VCH, Cheng JCK, Yip RML. Local steroid injection versus wrist splinting for carpal tunnel syndrome: A randomized clinical trial. Int J Rheum Dis. 2018 Jan;21(1):102-107. doi: 10.1111/1756-185X.13162. Epub 2017 Sep 13. — View Citation

Tagliafico A, Bodner G, Rosenberg I, Palmieri F, Garello I, Altafini L, Martinoli C. Peripheral nerves: ultrasound-guided interventional procedures. Semin Musculoskelet Radiol. 2010 Nov;14(5):559-66. doi: 10.1055/s-0030-1268066. Epub 2010 Nov 11. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carpal tunnel syndrome, Change in symptom severity from baseline to 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.	Baseline, 6 weeks
Primary	Carpal tunnel syndrome, Change in functional status from baseline to 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.	Baseline, 6 weeks
Primary	Carpal tunnel syndrome, Change in pain assessment from baseline to 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.	Baseline, 6 weeks
Secondary	Change in Median Nerve Dimensions	The median nerve dimensions at the carpal tunnel inlet is measured by high-resolution ultrasound. The diameter is measured in millimeters, and cross-sectional area calculated in square millimeters	Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Secondary	Carpal tunnel syndrome, Change in symptom severity at 12 weeks, 6 months, 1 year	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.	12 weeks, 6 months, 1 year
Secondary	Carpal tunnel syndrome, Change in functional status at 12 weeks, 6 months, 1 year	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.	12 weeks, 6 months, 1 year
Secondary	Carpal tunnel syndrome, Change in pain perception at 12 weeks, 6 months, 1 year	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.	12 weeks, 6 months, 1 year