Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome

NCT ID: NCT06243848

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2025-12-24

Brief Summary

The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Detailed Description

Carpal tunnel syndrome represents the most prevalent type of entrapment neuropathy. Anatomically, the carpal tunnel is formed by the carpal bones and lies beneath the transverse carpal ligament, housing nine tendon sheaths of the forearm flexors along with the median nerve. From a clinical perspective, individuals with carpal tunnel syndrome typically experience sensory symptoms such as paresthesia and hypoesthesia, as well as motor impairments and pain within the region supplied by the median nerve, all resulting from mechanical compression and localized ischemia.

In the classification of CTS, participants are diagnosed with mild, moderate, or severe CTS, and various treatment options are available for each category. Treatment options aimed at alleviating symptoms include physical therapy, splinting, wrist injections, and surgical procedures Ultrasound-guided injections of peripheral nerves are typically more advantageous than blind injections because minimize the risk of damaging crucial vascular structures in the adjacent tissue alongside the nerves and decrease the likelihood of intraneural injections.

CTS can also be treated surgically, although the literature has not provided sufficient evidence to establish the superiority of one surgical technique over another. However, these procedures are known to be effective by reducing the volume of the carpal tunnel, thereby relieving pressure on the median nerve. In CTS surgery, following a mini-incision, the dissection proceeds through fat and fascial tissue until the flexor retinaculum is reached, ensuring decompression of the median nerve. The advantages of the mini-incision technique include the preservation of neurovascular structures, a low risk of complications, and a high level of patient satisfaction, making it a prominent surgical approach.

The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with the classic minimal incision surgical technique for median nerve decompression in participants diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Conditions

Musculoskeletal Diseases; Median Nerve Disease; Carpal Tunnel Syndrome; Ultrasound-Guided Injection; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimal Incision Surgery for median nerve decompression

Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Group Type: ACTIVE_COMPARATOR

Minimal Incision Surgery for median nerve decompression

Intervention Type: PROCEDURE

Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Ultrasound-guided perineural injection with 5 cc 5% Dextrose

The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve.

Group Type: EXPERIMENTAL

Ultrasound-guided perineural injection with 5 cc 5% Dextrose

Intervention Type: PROCEDURE

The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve.

Interventions

Minimal Incision Surgery for median nerve decompression

Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

Intervention Type: PROCEDURE

Ultrasound-guided perineural injection with 5 cc 5% Dextrose

The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The presence of symptoms such as nocturnal, posture-related, or movement-related paresthesias, along with possible pain, in the area supplied by the median nerve in the hand, lasting for more than 3 months.
• Confirmation of mild, moderate or severe CTS through electrophysiological testing.
• Numbness and loss of sensation in the hand's regions innervated by the median nerve, as well as weakness in the thenar muscles innervated by the median nerve.
• Positive results on either the Phalen test and/or Tinel sign.

Exclusion Criteria

• Individuals who may exhibit symptoms mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
• Patients who have received a previous injection into the carpal tunnel within the past 6 months.
• Thenar muscle atrophy.
• A history of prior carpal tunnel surgery.
• Regular usage of systemic nonsteroidal anti-inflammatory drugs and corticosteroids.
• Pregnancy
• Patients diagnosed with rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, or polymyositis.
• Malignancy.
• Active infections

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Nuran Eyvaz

Asistant Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuran EYVAZ, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Ali İzzet AKÇİN, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ali İzzet AKÇİN, MD

Role: CONTACT

dr.akcin93@gmail.com

+905469347374

Nuran EYVAZ, MD

Role: CONTACT

n_eyvaz@hotmail.com

+905334262442

Facility Contacts

Ali İzzet AKÇİN, MD

Role: primary

dr.akcin93@gmail.com

+905469347374

Nuran EYVAZ, MD

Role: backup

n_eyvaz@hotmail.com

+905334262442

References

Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.

Reference Type: BACKGROUND

PMID: 36980446 (View on PubMed)

Lin MT, Liu IC, Syu WT, Kuo PL, Wu CH. Effect of Perineural Injection with Different Dextrose Volumes on Median Nerve Size, Elasticity and Mobility in Hands with Carpal Tunnel Syndrome. Diagnostics (Basel). 2021 May 9;11(5):849. doi: 10.3390/diagnostics11050849.

Reference Type: BACKGROUND

PMID: 34065073 (View on PubMed)

Pace V, Marzano F, Placella G. Update on surgical procedures for carpal tunnel syndrome: What is the current evidence and practice? What are the future research directions? World J Orthop. 2023 Jan 18;14(1):6-12. doi: 10.5312/wjo.v14.i1.6. eCollection 2023 Jan 18.

Reference Type: BACKGROUND

PMID: 36686281 (View on PubMed)

Other Identifiers

CTSHDvsOP

Identifier Type: -

Identifier Source: org_study_id