Comparison of Injection Techniques in Carpal Tunnel Syndrome

Ankara Etlik City Hospital

Status and phase: Invitation-only; Phase 4

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Betamethasone and local anesthetic; Drug: 5% Dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT07105540

AE-FTR-GST-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Hydrodissection group

Active Comparator group

Description:

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.

Treatment:

Drug: 5% Dextrose

Corticosteroid group

Active Comparator group

Description:

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.

Treatment:

Drug: Betamethasone and local anesthetic