Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome

NCT06349265 | Completed Phase 4

• 1 other identifier: 02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.

Conditions

Carpal Tunnel Syndrome

Keywords

dextrose; carpal tunnel syndrome; ultrasound

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale(VAS)

  VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line. The Turkish version of the assessment has been validated and shown to be reliable.

  At the beginning, 1.,4., 12. week

Secondary Outcomes (2)

• Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

  At the beginning, 1.,4., 12. week

• Dolour Neuropathique en 4 Questions (DN4) questionnaire

  At the beginning, 1.,4., 12. week

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Mild Carpal Tunnel syndrome

Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection

Group 2

ACTIVE COMPARATOR

Moderate Carpal Tunnel Syndrome

Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection

Group 3

ACTIVE COMPARATOR

Severe Carpal Tunnel Syndrome

Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection

Interventions

Carpal Tunnel Hydrodissection with %5 dextrose in water injection DRUG

Under the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
• Sensory loss with numbness in the median nerve-innervated regions of the hand.
• Weakness with atrophy of the median nerve-innervated thenar muscles.
• Positive Phalen's test and/or Tinel's sign.
• The diagnosis should be confirmed with electrodiagnostic studies.

You may not qualify if:

• History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
• History of systematic infection, and rheumatologic disorders.
• Previous steroid injection for carpal tunnel syndrome.

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Gamze Gül Güleç

Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

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)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Emre Özmen

  İstanbul Physical Medicine and Rehabilitation Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: October 2, 2023
• Primary Completion: February 2, 2024
• Study Completion: March 2, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)