Hydrodissection in Carpal Tunnel Syndrome

NCT ID: NCT07207460

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-08-01

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.

Conditions

Carpal Tunnel Syndrome; Median Nerve Entrapment

Study Design

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

Study Groups

ultrasound-guided in-plane injection technique

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

Comparison of three different injection techniques with D5W

ultrasound-guided out-of-plane injection technique

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

Comparison of three different injection techniques with D5W

blind technique

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

Comparison of three different injection techniques with D5W

Interventions

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

Comparison of three different injection techniques with D5W

Intervention Type: PROCEDURE

Other Intervention Names

land-mark technique; ultrasound-guided injection technique

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Berna Orhan

Physical Therapy and Rehabilitation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berna Orhan, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34213741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28943161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39894044 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30187524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25546691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32617017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33746745 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36974095 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27469410 (View on PubMed)

Other Identifiers

E2-23-4769

Identifier Type: -

Identifier Source: org_study_id