Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome

NCT04014244 | Unknown

• 1 other identifier: Treatment SZP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to compare the effectiveness of 5% dextrose, local corticosteroids injections and surgical release in patients with electrodiagnostically (EDx) mild to moderate carpal tunnel syndrome (CTS). The investigators hypothesize that in patients with mild to moderate CTS (1) local 5% dextrose injections is non-inferior to local corticosteroid injections at 12 months after treatment, and that (2) local 5% dextrose injections are of non-inferior effectiveness compared to surgical release at 6 months.

Conditions

Peripheral Nervous System Diseases; Nerve Compression Syndromes; Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Electromyography; Ultrasonography; Surgery; Dextrose; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Score

  The Visual Analog Scale (VAS) will be used to assess severity of digital paresthesia/dysesthesia and wrist or hand pain on 11-point grading scale. Scores ranges from from 0 to 10 points, with higher scores indicating greater severity of CTS symptoms (0 - no symptoms; 10 - extremely severe symptoms).

  1 years

Secondary Outcomes (6)

• Global Assessment of Treatment Results

  1 years

• Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Score

  1 years

• Median Nerve Distal Motor Latency (DML)

  1 years

• Ulnar and Median Antidromic Sensory Nerve Action Potentials (SNAPs)

  1 years

• Median Nerve Cross-sectional Area (CSA)

  1 years

Study Arms (2)

Corticosteroids vs. Dextrose

EXPERIMENTAL

In the first part of the study examiner will randomize substance for left hand infiltration using a dice (odd number - corticosteroids; even number - 5% glucose). Right hand will be infiltrated with the remaining substance.

Drug: Corticosteroid vs. Dextrose

Corticosteroids or Dextrose vs. Surgery

EXPERIMENTAL

In the second part of the study examiner will randomize treatment procedure for left hand using a dice (odd number - corticosteroids or 5% glucose; even number - surgery). Substance for injection will be determined according to the results of the first part of the study - more effective one, or in case of non-inferiority 5% glucose will be used. Surgical release will be performed by the same plastic surgeon. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.

Procedure: Corticosteroid or Dextrose vs. Surgery

Interventions

Corticosteroid vs. Dextrose DRUG

US guided injection of corticosteroid in one hand and 5% glucose in the other will be performed in accordance with randomization. In a syringe both substances will be diluted using 0.9% NaCl to a total injection volume of 6 ml. In-plane ulnar approach will be used to visualize the median nerve at the level of the pisiform bone. A standard 23 gauge needle will be inserted in the carpal tunnel with the needle tip positioned between retinaculum and median nerve.

Also known as: Triamcinolone injections versus 5% dextrose

Corticosteroids vs. Dextrose

Corticosteroid or Dextrose vs. Surgery PROCEDURE

Injection will be performed unilaterally, after randomization of sides, by the same examiner as in the first part of the study. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. The procedure will be performed under local anesthesia, following the same standard protocol. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.

Also known as: Triamcinolone injections or 5% dextrose versus Carpal tunnel release

Corticosteroids or Dextrose vs. Surgery

Eligibility Criteria

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

You may qualify if:

• numbness and tingling in at least two out of the first four digits;
• symptoms exacerbated during the night or in the morning, on holding the objects or repetitive use of the hand;
• symptoms relieved by shaking the hand or reposition of the arm.
• In addition to these clinical criteria for recruitment EDx confirmation will also be needed. Only patients with bilateral EDx mild to moderate CTS will be included.

You may not qualify if:

• polyneuropathy, symptoms of polyneuropathy, and all conditions causing polyneuropathy (e.g., diabetes);
• multiple mononeuropathy (e.g., hereditary neuropathy with liability to pressure palsies, syndrome Lewis Sumner);
• motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS);
• brachial plexopathy;
• other focal neuropathies affecting upper limbs (e.g., other median neuropathies, ulnar neuropathies, thoracic outlet syndrome); or
• previous surgery or local injections for CTS.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (25)

• Verdugo RJ, Salinas RS, Castillo J, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;(3):CD001552. doi: 10.1002/14651858.CD001552.

  PMID: 12917909 BACKGROUND

• Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.

  PMID: 17443508 BACKGROUND

• Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome: a randomized, placebo-controlled trial. Ann Intern Med. 2013 Sep 3;159(5):309-17. doi: 10.7326/0003-4819-159-5-201309030-00004.

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• Andreu JL, Ly-Pen D, Millan I, de Blas G, Sanchez-Olaso A. Local injection versus surgery in carpal tunnel syndrome: neurophysiologic outcomes of a randomized clinical trial. Clin Neurophysiol. 2014 Jul;125(7):1479-84. doi: 10.1016/j.clinph.2013.11.010. Epub 2013 Nov 23.

  PMID: 24321619 BACKGROUND

• Ly-Pen D, Andreu JL, de Blas G, Sanchez-Olaso A, Millan I. Surgical decompression versus local steroid injection in carpal tunnel syndrome: a one-year, prospective, randomized, open, controlled clinical trial. Arthritis Rheum. 2005 Feb;52(2):612-9. doi: 10.1002/art.20767.

  PMID: 15692981 BACKGROUND

• Ly-Pen D, Andreu JL, Millan I, de Blas G, Sanchez-Olaso A. Comparison of surgical decompression and local steroid injection in the treatment of carpal tunnel syndrome: 2-year clinical results from a randomized trial. Rheumatology (Oxford). 2012 Aug;51(8):1447-54. doi: 10.1093/rheumatology/kes053. Epub 2012 Mar 30.

  PMID: 22467087 BACKGROUND

• Celik G, Ilik MK. Effects of Two Different Treatment Techniques on the Recovery Parameters of Moderate Carpal Tunnel Syndrome: A Six-Month Follow-up Study. J Clin Neurophysiol. 2016 Apr;33(2):166-70. doi: 10.1097/WNP.0000000000000243.

  PMID: 26657237 BACKGROUND

• Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-de Jong B. Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice. BMC Fam Pract. 2010 Jul 29;11:54. doi: 10.1186/1471-2296-11-54.

  PMID: 20670438 BACKGROUND

• Ustun N, Tok F, Yagz AE, Kizil N, Korkmaz I, Karazincir S, Okuyucu E, Turhanoglu AD. Ultrasound-guided vs. blind steroid injections in carpal tunnel syndrome: A single-blind randomized prospective study. Am J Phys Med Rehabil. 2013 Nov;92(11):999-1004. doi: 10.1097/PHM.0b013e31829b4d72.

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• Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.

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  PMID: 24277115 BACKGROUND

• Wang JC, Liao KK, Lin KP, Chou CL, Yang TF, Huang YF, Wang KA, Chiu JW. Efficacy of Combined Ultrasound-Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):947-956. doi: 10.1016/j.apmr.2017.01.018. Epub 2017 Feb 14.

  PMID: 28209506 BACKGROUND

• Wang PH, Tsai CL, Lee JS, Wu KC, Cheng KI, Jou IM. Effects of topical corticosteroids on the sciatic nerve: an experimental study to adduce the safety in treating carpal tunnel syndrome. J Hand Surg Eur Vol. 2011 Mar;36(3):236-43. doi: 10.1177/1753193410390760. Epub 2011 Jan 31.

  PMID: 21282223 BACKGROUND

• Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.

  PMID: 28778254 BACKGROUND

• Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.

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• Dufour E, Donat N, Jaziri S, Kurdi O, Couturier C, Dreyfus JF, Fischler M. Ultrasound-guided perineural circumferential median nerve block with and without prior dextrose 5% hydrodissection: a prospective randomized double-blinded noninferiority trial. Anesth Analg. 2012 Sep;115(3):728-33. doi: 10.1213/ANE.0b013e31825fa37d. Epub 2012 Jun 28.

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  PMID: 28770310 BACKGROUND

• Gonzalez-Suarez CB, Fidel BC, Cabrera JTC, Dela Cruz FC, Gesmundo MVT, Regala CFG, Saratan R, Suarez CG, Grimmer K. Diagnostic Accuracy of Ultrasound Parameters in Carpal Tunnel Syndrome: Additional Criteria for Diagnosis. J Ultrasound Med. 2019 Nov;38(11):3043-3052. doi: 10.1002/jum.15012. Epub 2019 Apr 17.

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MeSH Terms

Conditions

Peripheral Nervous System Diseases; Nerve Compression Syndromes; Carpal Tunnel Syndrome

Interventions

Glucose; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Gregor Omejec, PT, DSc

CONTACT

+386 1 522 1502; gregor.omejec@kclj.si

Simon Podnar, MD

CONTACT

+386 1 522 3076; simon.podnar@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Each of three investigators performing one part of diagnostic evaluation (history and focal neurologic examination, EDx and (3) ultrasonographic (US) studies) will be blinded for findings of other parts of evaluation. Furthermore, patients will be blinded for laterality of the injected substance.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with bilateral CTS symptoms and EDx mild to moderate CTS will be included. In the first part of the study examiner will randomize substance for left hand infiltration using a dice (odd number - corticosteroids; even number - 5% glucose). Right hand will be infiltrated with the remaining substance. In the second part of the study examiner will randomize treatment procedure for left hand using a dice (odd number - corticosteroids or 5% glucose; even number - surgery). Substance for injection will be determined according to the results of the first part of the study - more effective one, or in case of non-inferiority 5% glucose will be used. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2023
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)