Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone in Carpal Tunnel Syndrome

NCT06045013 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 510.01/23-01/76
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, randomized, double-blinded, head-to-head comparative study is to compare the efficacy of ultrasound-guided 4 ml 5% dextrose perineural injection versus 3 ml 5% dextrose with 1 ml 40 mg/ml methylprednisolone perineural injection in patients with carpal tunnel syndrome (CTS). The main questions it aims to answer are: Is there a difference in efficacy between interventions regarding 1. pain alleviation, 2. improvement in symptoms severity and functional status, 3. improvement in grip strength, 4. size of median nerve cross-sectional area, and 5. improvement in quality of life during the six-month post-intervention follow-up period?

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Ultrasonography; Injections; Glucose; Glucocorticoids; Pain; Functional Status; Hand Strength, Quality of Life

Outcome Measures

Primary Outcomes (1)

• Pain intensity at 4 weeks post injection

  Assessment of pain intensity using 10 cm Visual Analogue Scale (VAS pain), 0-10; 0=no pain, 10=the most severe pain.

  before injection, 4 weeks post injection

Secondary Outcomes (5)

• Pain intensity at 12 and 24 weeks post injection

  before injection,12 and 24 weeks post injection.

• Symptoms severity and functional impairment of carpal tunnel syndrome (CTS)

  before injection, 4, 12 and 24 weeks post injection.

• Grip strength

  before injection, 4, 12 and 24 weeks post injection.

• Median nerve cross-sectional area (CSA)

  before injection, 4, 12 and 24 weeks post injection.

• Quality of life (QoL)

  before injection, 4, 12 and 24 weeks post injection.

Study Arms (2)

5% dextrose injection

ACTIVE COMPARATOR

Ultrasound-guided 4 ml single injection of 5% dextrose

Drug: 5% dextrose injection

5% dextrose injections with methylprednisolone acetate

ACTIVE COMPARATOR

Ultrasound-guided single injection of 3 ml 5% dextrose plus 1 ml 40 mg/ml methylprednisolone acetate

Drug: 5% dextrose injections with methylprednisolone acetate 40 mg/ml

Interventions

5% dextrose injection DRUG

Single ultrasound-guided injection of 4 ml 5% dextrose in carpal tunnel via ulnar approach.

Also known as: 5% dextrose

5% dextrose injection

5% dextrose injections with methylprednisolone acetate 40 mg/ml DRUG

Single ultrasound-guided injection of 3 ml 5% dextrose with 1 ml 40 mg/ml methylprednisolone acetate in carpal tunnel via ulnar approach.

Also known as: Depo-Medrol 40 mg/ml

5% dextrose injections with methylprednisolone acetate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 80 years,
• the diagnosis of idiopathic CTS.

You may not qualify if:

• contraindications for local application of methylprednisolone or 5% dextrose (hypersensitivity to the drug, infection and skin damage at the application site),
• previous wrist surgery,
• traumatic wrist injury within 2 years,
• previous wrist injection within 6 months,
• previous physical therapy within 6 months,
• history of peripheral traumatic nerve injury in the upper extremity, brachial plexopathy, severe cervical radiculopathy, and thoracic outlet syndrome,
• history of diabetes
• history of thyroid disease,
• history of inflammatory rheumatic disease,
• pregnancy,
• inability to cooperate with the study protocol.

Sponsors & Collaborators

• General and Veteran Hospital Croatian Pride Knin: lead
• Clinical Hospital Centre Zagreb: collaborator
• School of Public Health Andrija Štampar: collaborator

Study Sites (1)

General and Veteran Hospital "Croatian Pride" Knin

Knin, 22300, Croatia

RECRUITING

Related Publications (7)

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

  PMID: 19897823 BACKGROUND

• Gao N, Yan L, Ai F, Kang J, Wang L, Weng Y. Comparison of the Short-Term Clinical Effectiveness of 5% Dextrose Water, Platelet-rich Plasma and Corticosteroid Injections for Carpal Tunnel Syndrome: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2023 May;104(5):799-811. doi: 10.1016/j.apmr.2022.11.009. Epub 2022 Dec 16.

  PMID: 36529261 BACKGROUND

• Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.

  PMID: 33391002 BACKGROUND

• Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

  PMID: 8245050 BACKGROUND

• Klauser AS, Halpern EJ, De Zordo T, Feuchtner GM, Arora R, Gruber J, Martinoli C, Loscher WN. Carpal tunnel syndrome assessment with US: value of additional cross-sectional area measurements of the median nerve in patients versus healthy volunteers. Radiology. 2009 Jan;250(1):171-7. doi: 10.1148/radiol.2501080397. Epub 2008 Nov 26.

  PMID: 19037017 BACKGROUND

• Elnady B, Rageh EM, Ekhouly T, Fathy SM, Alshaar M, Fouda ES, Attar M, Abdelaal AM, El Tantawi A, Algethami MM, Bong D. Diagnostic potential of ultrasound in carpal tunnel syndrome with different etiologies: correlation of sonographic median nerve measures with electrodiagnostic severity. BMC Musculoskelet Disord. 2019 Dec 29;20(1):634. doi: 10.1186/s12891-019-3010-5.

  PMID: 31884951 BACKGROUND

Related Links

• Randomization of patients into two groups will be carried out with the help of the above-listed web application.

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain

Interventions

Glucose; Methylprednisolone Acetate

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Igor Begović, MD

  General and Veteran Hospital "Croatian Pride" Knin, Croatia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Begović, MD

CONTACT

+385911748137; igorbegovic2@gmail.com

Nadica Laktašić Žerjavić, Prof,MD,PhD.

CONTACT

+385915606957; nadica_laktasic@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical medicine and rehabilitation specialist

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 13, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CR (1)