Comparison of Injection Techniques in Carpal Tunnel Syndrome

NCT07105540 | Completed Phase 4

• 1 other identifier: AE-FTR-GST-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of ultrasound-guided hydrodissection with 5% dextrose and perineural corticosteroid injection on the clinical parameters of carpal tunnel syndrome, as well as to evaluate the long-term efficacy of these treatments.

Conditions

Carpal Tunnel Syndrome

Keywords

Hydrodissection; Perineural Injection; Median Nerve

Outcome Measures

Primary Outcomes (1)

• Boston Carpal Tunnel Questionnaire

  The Boston Carpal Tunnel Questionnaire (BCTQ) is a validated disease-specific assessment tool developed in 1993 to provide standardized clinical evaluation of carpal tunnel syndrome (CTS). It comprises 19 items divided into two subscales: the Symptom Severity Scale (BCTQ-SSS) and the Functional Status Scale (BCTQ-FSS). Scores on both subscales range from 1 to 5, with higher scores reflecting increased symptom burden and functional impairment associated with CTS.

  At baseline, at Month 1,3,6 (Visit 1,2,3)

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

  At baseline and at Month 1,3,6 (Visit 1,2,3)

• Cross-Sectional Area (CSA) of the Median Nerve via Ultrasonography

  At baseline and at month 3,6 (Visit 2,3)

• Hand Grip Strength

  At baseline and at Month 3,6 (Visit 2,3)

Study Arms (2)

Hydrodissection group

ACTIVE COMPARATOR

Participants in the hydrodissection group will undergo ultrasound-guided perineural hydrodissection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). Under sterile conditions, 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml.

Drug: 5% Dextrose

Corticosteroid group

ACTIVE COMPARATOR

Participants in the corticosteroid group will undergo ultrasound-guided perineural injection of the median nerve at the scaphoid-pisiform level using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare, Boston, MA). A perineural injection of 1 ml betamethasone combined with 1 ml 2% lidocaine will be administered around the median nerve.

Drug: Betamethasone and local anesthetic

Interventions

5% Dextrose DRUG

Ultrasound-guided hydrodissection is performed using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare) via an in-plane ulnar approach under sterile conditions. 2.5 ml of 5% dextrose will be injected via an in-plane ulnar approach to mechanically separate the median nerve from the transverse carpal ligament. Subsequently, an additional 2.5 ml of 5% dextrose will be administered to separate the nerve from adjacent flexor tendons. The total injection volume will be 5 ml.

Hydrodissection group

Betamethasone and local anesthetic DRUG

Ultrasound-guided perineural injection is performed using a 12 MHz linear transducer (GE Logiq P9, GE Healthcare) via an in-plane ulnar approach under sterile conditions. A total of 2 ml solution (1 ml betamethasone and 1 ml 2% lidocaine) is injected perineurally around the median nerve under ultrasound guidance at the scaphoid-pisiform level.

Corticosteroid group

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with unilateral moderate carpal tunnel syndrome (CTS) confirmed by an electrophysiological study within the last 6 months
• Presence of at least one of the following symptoms lasting more than one month:
• Paresthesia/dysesthesia accompanied by weakness and clumsiness in the hand, worsened by repetitive wrist use or sleep, and relieved by postural correction or shaking of the hand
• Numbness due to sensory disturbance in the median nerve (MN) distribution
• Thenar muscle weakness with atrophy
• Positive Tinel's sign or Phalen's test
• Pain intensity of ≥4 out of 10 on the Visual Analog Scale (VAS) prior to treatment

You may not qualify if:

• History of previous wrist surgery, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome
• Presence of systemic infection
• Pregnancy
• Prior corticosteroid injection for CTS

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06370, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Glucose; Betamethasone; Anesthetics, Local

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)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 6, 2025
• Study Start: August 5, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)