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

NCT04579783 | Unknown

• 1 other identifier: 202007021MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Hydro-dissection; Dextrose; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Visual analogue scale

  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)

  change of the score between 12 weeks and baseline (1st injection)

• Amplitude of median nerve sensory nerve action potential (Unit: μV)

  change of the score between 12 weeks and baseline (1st injection)

• Distal latency of median nerve compound motor action potential (Unit: ms)

  change of the score between 12 weeks and baseline (1st injection)

• Amplitude of median nerve compound motor action potential (Unit: mV)

  change of the score between 12 weeks and baseline (1st injection)

Study Arms (2)

Ultrasound intracarpal corticosteroid injection

ACTIVE COMPARATOR

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

Ultrasound guided intracarpal dextrose hydro-dissection

ACTIVE COMPARATOR

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

Interventions

Triamcinolone Acetonide DRUG

Group A: 40mg triamcinolone acetonide (1mL) + 4mL normal saline

Also known as: Shincort

Ultrasound intracarpal corticosteroid injection

Dextrose 5% in water DRUG

Group B: 5mL 5% dextrose

Also known as: Vitagen

Ultrasound guided intracarpal dextrose hydro-dissection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Wanhua District, 108, Taiwan

RECRUITING

Related Publications (1)

• 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

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Triamcinolone Acetonide; Glucose; Water

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)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Ke-Vin Chang, MD,PhD

  National Taiwan University Hospital Beihu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Vin Chang, MD, PhD

CONTACT

+886-2-23712121; kvchang011@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 8, 2020
• Study Start: November 27, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)