Hydrodissection in Carpal Tunnel Syndrome

NCT07207460 | Completed

• 1 other identifier: E2-23-4769
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Median Nerve Entrapment

Keywords

Carpal Tunnel Syndrome; perineural injection; nerve hydrodissection; Conservative treatment; Entrapment neuropathy; 5% dextrose; ultrasound-guided hydrodissection

Outcome Measures

Primary Outcomes (3)

• Boston CTS

  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.

  0 , 2nd week 12th week

• VAS

  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).

  0 2nd week 12th week

• DN-4

  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).

  0 2nd week 12th week

Secondary Outcomes (2)

• Nerve CSA

  0 2nd 12th week

• EMG

  0 and 12th week

Study Arms (3)

ultrasound-guided in-plane injection technique

ACTIVE COMPARATOR

With the patient seated, the lower third of the forearm and the entire palm were sterilized using 2% povidone-iodine. A sterile cover was applied to the ultrasound probe, and sterile gel was placed on the skin. The probe was positioned transversely at the palmar wrist crease at the entrance of the carpal tunnel, allowing visualization of the pisiform, ulnar nerve, and ulnar artery . The ulnar nerve lies just radial to the pisiform, with the ulnar artery located radial to the ulnar nerve; Doppler imaging was used when necessary to confirm arterial position. After identifying the median nerve with ultrasound, a 22-gauge, 38 mm needle was advanced via the ulnar approach. The ulnar nerve and artery were visualized throughout the procedure. The needle was first advanced to the inferior surface of the median nerve with the bevel facing upward; following negative aspiration, 2.5 mL of 5% dextrose solution was injected. Without removing the needle from the skin, the bevel was then r

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

ultrasound-guided out-of-plane injection technique

ACTIVE COMPARATOR

The patient was seated, and the lower third of the forearm and the entire palm were sterilized with 2% povidone-iodine. A sterile drape covered the ultrasound probe, and sterile gel was applied to the skin. The probe was placed transversely at the proximal wrist crease to visualize the median nerve, then shifted ulnarly to identify the pisiform, ulnar nerve, and ulnar artery. Doppler imaging was used when necessary to confirm arterial position. For the out-of-plane technique, a proximal-to-distal longitudinal approach was employed. With the median nerve visualized, a 22-gauge, 38 mm needle was inserted, and after negative aspiration, 5 mL of 5% dextrose solution was injected between the median nerve and the flexor retinaculum

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

blind technique

ACTIVE COMPARATOR

This injection technique relies on anatomical landmarks, targeting the space between the palmaris longus tendon and the flexor carpi radialis. The patient was seated, and the lower third of the forearm and the entire palm were sterilized using 2% povidone-iodine. The most commonly used landmarks for the blind approach were the ulnar edge of the palmaris longus tendon and the proximal wrist crease. A 22-gauge, 38 mm needle was inserted at the ulnar border of the palmaris longus tendon along the scaphoid-pisiform line and advanced distally toward the ring finger at an angle of approximately 30°-45°. In patients lacking a palmaris longus tendon, the needle was inserted just ulnar to the wrist midline. Upon patient-reported paresthesia, the needle was slightly withdrawn and redirected ulnarly. Aspiration was performed in all cases to avoid intravascular injection, and 5 mL of 5% dextrose solution was administered slowly and steadily.

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

Interventions

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

Also known as: land-mark technique, ultrasound-guided injection technique

blind technique; ultrasound-guided in-plane injection technique; ultrasound-guided out-of-plane injection technique

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (9)

• Mathieu T, Lemmens E, Stassijns G. A safe and easy-to-use ultrasound-guided hydrodissection technique for the carpal tunnel syndrome: a minimally invasive approach. J Ultrasound. 2022 Sep;25(3):451-455. doi: 10.1007/s40477-021-00597-5. Epub 2021 Jul 2.

  PMID: 34213741 BACKGROUND

• Babaei-Ghazani A, Roomizadeh P, Forogh B, Moeini-Taba SM, Abedini A, Kadkhodaie M, Jahanjoo F, Eftekharsadat B. Ultrasound-Guided Versus Landmark-Guided Local Corticosteroid Injection for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Apr;99(4):766-775. doi: 10.1016/j.apmr.2017.08.484. Epub 2017 Sep 21.

  PMID: 28943161 BACKGROUND

• Lee K, Park JM, Yoon SY, Kim MS, Kim YW, Shin JI, Lee SC. Ultrasound-Guided Nerve Hydrodissection for the Management of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Yonsei Med J. 2025 Feb;66(2):111-120. doi: 10.3349/ymj.2024.0089.

  PMID: 39894044 BACKGROUND

• Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.

  PMID: 30187524 BACKGROUND

• Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.

  PMID: 25546691 BACKGROUND

• Babaei-Ghazani A, Forogh B, Raissi GR, Ahadi T, Eftekharsadat B, Yousefi N, Rahimi-Dehgolan S, Moradi K. Ultrasound-Guided Corticosteroid Injection in Carpal Tunnel Syndrome: Comparison Between Radial and Ulnar Approaches. J Pain Res. 2020 Jun 26;13:1569-1578. doi: 10.2147/JPR.S248600. eCollection 2020.

  PMID: 32617017 BACKGROUND

• Buntragulpoontawee M, Chang KV, Vitoonpong T, Pornjaksawan S, Kitisak K, Saokaew S, Kanchanasurakit S. The Effectiveness and Safety of Commonly Used Injectates for Ultrasound-Guided Hydrodissection Treatment of Peripheral Nerve Entrapment Syndromes: A Systematic Review. Front Pharmacol. 2021 Mar 5;11:621150. doi: 10.3389/fphar.2020.621150. eCollection 2020.

  PMID: 33746745 BACKGROUND

• Cage ES, Beyer JJ, Ebraheim NA. Injections for treatment of carpal tunnel syndrome: A narrative review of the literature. J Orthop. 2023 Feb 21;37:81-85. doi: 10.1016/j.jor.2023.02.011. eCollection 2023 Mar.

  PMID: 36974095 BACKGROUND

• Borire AA, Hughes AR, Lueck CJ, Colebatch JG, Krishnan AV. Sonographic differences in carpal tunnel syndrome with normal and abnormal nerve conduction studies. J Clin Neurosci. 2016 Dec;34:77-80. doi: 10.1016/j.jocn.2016.05.024. Epub 2016 Jul 25.

  PMID: 27469410 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Charcot-Marie-Tooth Disease

Interventions

Glucose

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Berna Orhan, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was conducted by four independent researchers. One investigator confirmed the CTS diagnosis using EMG and performed all follow-up EMG assessments. A second investigator measured the CSA using ultrasound. A third investigator performed all injections, while a fourth investigator was responsible for clinical evaluations and statistical analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy and Rehabilitation Specialist

Model Details: This study was designed as a randomized, controlled, single-blind trial. Patients diagnosed with mild or moderate CTS based on EMG findings were randomly assigned into three groups using a computerized randomization method. Perineural hydrodissection was performed with 5 mL of 5% dextrose solution in all groups: Group 1 with the in-plane US-guided ulnar approach, Group 2 with the out-of-plane US-guided proximal-to-distal ulnar approach, and Group 3 with the blind proximal-to-distal longitudinal approach. Assessments were conducted at baseline, 2 weeks, and 3 months after the injection. Outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the DN4 questionnaire for CTS severity and functional status, as well as pain intensity assessed using a Visual Analog Scale (VAS). Median nerve cross-sectional area (CSA) was measured at baseline by a physician with over 10 years of US experience, and electromyography (EMG) evaluations were performed at baseline and 3 m

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 6, 2025
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)