Skip to main content
OpenTrials
Completed

NCT Number: NCT07207460

Hydrodissection in Carpal Tunnel Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carpal Tunnel Syndrome Charcot-Marie-Tooth Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cumulative Trauma Disorders Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Median Nerve Entrapment Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Sprains and Strains Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS

Procedure

Comparison of three different injection techniques with D5W

Other names: land-mark technique, ultrasound-guided injection technique

Primary outcomes

  1. Boston CTS

    Time frame: 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.

  2. VAS

    Time frame: 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).

  3. DN-4

    Time frame: 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 outcomes

  1. Nerve CSA

    Time frame: 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.

  2. EMG

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of Hydrodissection Techniques Using 5% Dextrose for the Treatment of Carpal Tunnel Syndrome

Acronym: KTS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.