Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients

Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients

Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. The investigators aim to compare the therapeutic effect of 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Triamcinolone Acetonide; Drug: Dextrose 5% in water

Detailed Description

Introduction:

Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. Whether repeated injection could expand the treatment effect was undetermined. The investigators aim to compare the therapeutic effect repeated 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.

Material and methods:

Participants: 60 adult patients (>20 year olds) with carpal tunnel syndrome, recruited from outpatient clinic.

Inclusion criteria: Presenting with CTS symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand. Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree. Persistent symptoms for more than 3 months

Exclusion Criteria: Patients cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome. Recent corticosteroid injection to the carpal tunnel within 6 months.

Thenar muscle atrophy. Previous history of carpal tunnel surgical release. History of wrist trauma. Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics. Pregnancy. Cognitive impairment.

Objective:

The aim of this study is to compare the treatment effect of repeated 5 mL 5% dextrose with 5mL triamcinolone acetonide injection in patients with CTS.

Detail of the intervention The study is designated as randomized, double blinded, and parallel experiment. The randomization was decided by random table in block of 4.

Repeated ultrasound guided injection intracarpal median nerve hydro-dissection with 5 mL 5% dextrose (Group B) or 5mL triamcinolone acetonide injection (Group A) in patients with CTS.

The regimen was shown as below:

Group A: 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose

Skin infiltration with local anesthetic (lidocaine cream) at the needle insertion site was performed before the injection. Then injection was performed after sterilization. The equipment for ultrasound-guided injection will be high-resolution ultrasound machine with the linear probe.

Outcome measurement:

Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Visual analogue scale (VAS) before 1st injection, before 2nd injection (6-week) and 12-week after first injection.

Electrophysiological evaluation (amplitude and distal latency of median nerve compound motor action potential and sensory nerve action potential); cross-sectional area of median nerve at carpal tunnel inlet, were evaluated before and 12-week after 1st injection.

Global assessment of treatment was evaluated at before 2nd injection (6-week) and 12-week after first injection.

Statistical analysis:

Continuous variables Student's t test: fit assumption of normal distribution Mann-Whitney test: does not fit the assumption of normal distribution Categorical variables (1) Chi-square test (2) Fisher exact test: sparse data (3)Repeated-measures analysis of variance (ANOVA) was used to evaluate the effect of injection with post-hoc Bonferroni test to evaluate intra-group data at different time-frame

Keywords: Hydro-dissection, corticosteroid, dextrose, carpal tunnel syndrome

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke-Vin Chang, MD, PhD; Phone Number: 5309 +886-2-23712121; Email: kvchang011@gmail.com

Study Locations

• Taiwan
  • Wanhua District
    • Taipei, Wanhua District, Taiwan, 108
      • Recruiting
      • National Taiwan University Hospital, Bei-Hu Branch
      • Contact: Ke-Vin Chang, MD, PhD; Email: kvchang011@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presenting with carpal tunnel syndrome symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand
• Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree
• Persistent symptoms for more than 3 months

Exclusion Criteria:

• Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
• Recent corticosteroid injection to the carpal tunnel within 6 months
• Thenar muscle atrophy
• Previous history of carpal tunnel surgical release
• History of wrist trauma
• Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics
• Pregnancy
• Cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ultrasound intracarpal corticosteroid injection; Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. 1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL ) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline	Drug: Triamcinolone Acetonide; Group A: 40mg triamcinolone acetonide (1mL) + 4mL normal saline; Other Names: Shincort
ACTIVE_COMPARATOR: Ultrasound guided intracarpal dextrose hydro-dissection; Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level. Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose	Drug: Dextrose 5% in water; Group B: 5mL 5% dextrose; Other Names: Vitagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Syndrome Questionnaire	Evaluation of symptom severity (11-question) and functional impairment (8-question) subscale. The scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.	Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	Pain intensity evaluation, from 0 to 10 points, a 11-point scale. The higher scores indicate severe pain.	Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Distal latency of median nerve sensory nerve action potential (Unit: ms)	recoding at index finger by antidromic stimulation	change of the score between 12 weeks and baseline (1st injection)
Amplitude of median nerve sensory nerve action potential (Unit: μV)	recording at index finger by antidromic stimulation	change of the score between 12 weeks and baseline (1st injection)
Distal latency of median nerve compound motor action potential (Unit: ms)	recording at abductor pollicis brevis muscle	change of the score between 12 weeks and baseline (1st injection)
Amplitude of median nerve compound motor action potential (Unit: mV)	recording at abductor pollicis brevis muscle	change of the score between 12 weeks and baseline (1st injection)
Cross-sectional area of median nerve (unit: mm2)	Ultrasound evaluation of the median nerve size	Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Global assessment of treatment (1st)	self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)	6-week after 1st injection (before 2nd injection)
Global assessment of treatment (2nd)	self-reported global assessment of treatment on 5 category (much improved, improved, no change, worse, or much worse)	6-week after 2nd injection (12-week after 1st injection)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ke-Vin Chang, MD,PhD, National Taiwan University Hospital Beihu Branch

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2020
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Corticosteroid; Dextrose; Hydro-dissection
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 202007021MINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No