Comparison of Injection Techniques in Carpal Tunnel Syndrome

NCT ID: NCT07105540

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-02-05

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.

Detailed Description

Carpal tunnel syndrome (CTS), the most prevalent peripheral compressive neuropathy, manifests primarily with sensory disturbances such as pain, numbness, and nocturnal paresthesia. Treatment options for CTS differ considerably depending on the severity of symptoms, and typically include splinting, physiotherapy, local injection therapies, and surgical release. Hydrodissection is an ultrasound-guided technique that has recently gained increased attention for its role in the management of nerve entrapment syndromes. The technique uses fluid injection to separate the nerve from nearby tissues. This may reduce perineural adhesions and improve the patient's symptoms. In hydrodissection, normal saline, 5% dextrose, or platelet-rich plasma (PRP) can be used as injectates. Recently, hydrodissection with 5% dextrose has become the most commonly used approach. Several studies in the literature have demonstrated that perineural hydrodissection with 5% dextrose provides more favorable outcomes than corticosteroid injections in patients with mild to moderate CTS, particularly at 4 to 6 months post-injection. However, it remains unclear whether hydrodissection leads to a reduction in the cross-sectional area of the median nerve. In addition, studies examining the procedural details of hydrodissection are limited. Therefore, further clinical research is needed to better understand and validate the technique.

Ultrasound-guided hydrodissection for CTS is performed using a 12 MHz linear array transducer probe (GE Logiq P9, GE Healthcare, Boston, MA). The median nerve (MN) is visualized at the scaphoid-pisiform level. In the intervention group, 2.5 ml of 5% dextrose is injected via an in-plane ulnar approach to separate the MN from the transverse carpal ligament, followed by an additional 2.5 ml of normal saline (NS) injected to separate the MN from the flexor tendons. In the control group, perineural injection of 1 ml betamethasone is administered around the MN using the same ultrasound device and probe.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hydrodissection group

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.

Group Type: ACTIVE_COMPARATOR

5% Dextrose

Intervention Type: 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.

Corticosteroid group

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.

Group Type: ACTIVE_COMPARATOR

Betamethasone and local anesthetic

Intervention Type: 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.

Interventions

5% Dextrose

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.

Intervention Type: DRUG

Betamethasone and local anesthetic

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gizem Suna Tuncer

Principal Investigator, Physical Medicine and Rehabilitation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AE-FTR-GST-01

Identifier Type: -

Identifier Source: org_study_id