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

NCT04515966 | Unknown Phase 4 FDA Drug

• 1 other identifier: 20-006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

wrist splint; steroid injection; median nerve ultrasound

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Change in Median Nerve Dimensions

  Baseline, 6 weeks, 12 weeks, 6 months, 1 year

• Carpal tunnel syndrome, Change in symptom severity at 12 weeks, 6 months, 1 year

  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

Study Arms (2)

Ultrasound-guided steroid injection

ACTIVE COMPARATOR

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.

Drug: Methylprednisolone Injection [Solu-Medrol]

Wrist splint

ACTIVE COMPARATOR

Participants in this arm are treated with a wrist splint.

Device: wrist splint

Interventions

Methylprednisolone Injection [Solu-Medrol] DRUG

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.

Also known as: Lidocaine, 1% solution

Ultrasound-guided steroid injection

wrist splint DEVICE

A standard wrist splint

Wrist splint

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mercy Health Ohio: lead

Study Sites (1)

St. Elizabeth Boardman Family Medicine

Boardman, Ohio, 44512, United States

RECRUITING

Related Publications (13)

• Klauser AS, Halpern EJ, Faschingbauer R, Guerra F, Martinoli C, Gabl MF, Arora R, Bauer T, Sojer M, Loscher 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.

  PMID: 21386049 BACKGROUND

• 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.

  PMID: 21845577 BACKGROUND

• Karadas O, 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.

  PMID: 22674243 BACKGROUND

• 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.

  PMID: 21072732 BACKGROUND

• 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.

  PMID: 30343858 BACKGROUND

• 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.

  PMID: 27751557 BACKGROUND

• Middleton SD, Anakwe RE. Carpal tunnel syndrome. BMJ. 2014 Nov 6;349:g6437. doi: 10.1136/bmj.g6437. No abstract available.

  PMID: 25378457 BACKGROUND

• 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.

  PMID: 29499823 BACKGROUND

• 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.

  PMID: 25177448 BACKGROUND

• 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.

  PMID: 19782873 BACKGROUND

• 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.

  PMID: 28901660 BACKGROUND

• 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.

  PMID: 27696773 BACKGROUND

• 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.

  PMID: 26962518 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Lidocaine; Solutions

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations

Study Officials

• Roy N. Morcos, M.D.

  Bon Secours Mercy Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy N. Morcos, M.D.

CONTACT

(330)729-8700; roy_morcos@mercy.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Family and Community Medicine

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 17, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)