Hydrodissection in Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome; Median Nerve Entrapment

• Registration Number: NCT07207460
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The aim of this study was to compare the effectiveness of perineural hydrodissection methods performed with 5 mL D5W solution and three different injection techniques \[ultrasound-guided in-plane, ultrasound-guided out-of-plane, and blind technique\] in cases diagnosed with mild to moderate CTS by EMG.

Detailed Description

Carpal tunnel syndrome (CTS) is a highly prevalent condition in the general population, markedly impairing daily activities and sleep quality. Depending on disease severity and symptom burden, treatment approaches are broadly categorized as conservative or surgical. Beyond lifestyle modifications, numerous conservative interventions-including splinting, extracorporeal shock wave therapy, therapeutic ultrasound, phonophoresis, hydrodissection, kinesiotaping, corticosteroid (CS) injections, low-level laser therapy, platelet-rich plasma (PRP) injections, manual therapy, and acupuncture-have demonstrated clinical efficacy. More recently, 5% dextrose injections have emerged as a safe alternative to CS with minimal adverse effects. Injection therapies vary in both content and technique; however, no consensus exists regarding the optimal approach. Given the importance of minimizing side effects and ensuring long-term effectiveness, the refinement of injection agents and techniques remains a priority. Although ultrasound-guided injections improve safety and accuracy, they require expertise and incur additional costs, whereas blind techniques have long been applied reliably in clinical practice. Nevertheless, comparative studies evaluating these techniques remain limited. Therefore, the present study aimed to compare three different injection techniques for the management of CTS.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-08-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients between the ages of 20-70
• Moderate and mild CTS patients diagnosed with CTS by EMG
• Literate patients who agreed to participate in the study

Exclusion Criteria

• Patients with RA, type 1 or type 2 diabetes mellitus
• Patients with chronic renal failure
• Polyneuropathy
• Those with a history of cancer, those receiving chemotherapy
• Those with a history of broken hand wrist fracture in the last 6 months
• Patients with brachial plexopathy or thoracic outlet syndrome (TOS)
• Patients who underwent surgery due to CTS
• Pregnancy
• Hypothyroidism in a mixed edema picture
• Diagnosed with neuromuscular disease
• Patients with bleeding disorders or those currently receiving anticoagulant therapy
• patients with infection at the injection site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Boston CTS	0 , 2nd week 12th week	The BCTQ is the most widely used measure for CTS. It includes 2 subscales with 11 questions assessing symptom severity and 8 questions assessing functional status.31 Scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.The BCTQ provides a standardized, patient-based outcome measure of symptom severity and functional status to assess the results of carpal tunnel syndrome treatments. The test has strong evidence of validity, reliability and responsiveness.
VAS	0 2nd week 12th week	VAS was used to assess digital pain intensity and paresthesia/dysthesia before injection therapy administration. Scores ranged from 10 (extremely severe pain) to 0 (no pain).
DN-4	0 2nd week 12th week	It is a clinical screening tool used to diagnose the presence of neuropathic pain.It was developed by the French Neuropathic Pain Group to address the difficulties and lack of consensus in diagnosing neuropathic pain.It is a questionnaire consisting of 10 items administered by the clinician.Seven pain-related items (i.e., sensory and pain descriptors) are administered in consultation with the patient. They express how pain is felt by the patient.The three items are based on clinical examination. The clinician assesses whether sensation to touch or pinprick is diminished (hyposthesia) and whether it increases with light brushing or causes pain (allodynia).

Secondary Outcome Measures

Name	Time	Method
Nerve CSA	0 2nd 12th week	The cross-sectional area (CSA) of the median nerve was measured at baseline, 2 weeks, and 3 months after injection by a physician with over 10 years of ultrasound experience. Patients were seated with the forearm supinated and the wrist in slight dorsiflexion, supported by a rolled towel or pillow. A high-frequency linear probe (5-12 MHz, Logic P5, GE Medical Systems) was placed on the palmar wrist in the transverse plane. The median nerve was identified at the level of the scaphoid (radial side) and pisiform (ulnar side), typically in the midline beneath the superficial flexor tendons. CSA was measured by tracing the inner border of the perineural echogenic rim. Each measurement was repeated three times, and the mean value was recorded.
EMG	0 and 12th week	Using electrophysiological studies, CTS degree (distal motor latency \[DML\]) greater than 3.6 was considered as moderate CTS, and those less than 3.6 as mild CTS. Only participants with mild-to-moderate CTS were included in the study.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; Ankara, Turkey (Türkiye)