NCT06243848

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Jan 2024May 2026

First Submitted

Initial submission to the registry

January 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2026

Expected
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

January 25, 2024

Last Update Submit

March 10, 2026

Conditions

Musculoskeletal DiseasesMedian Nerve DiseaseCarpal Tunnel SyndromeUltrasound-Guided InjectionSurgery

Keywords

Carpal Tunnel SyndromeUltrasound-Guided InjectionMedian Nerve Decompression

Outcome Measures

Primary Outcomes (1)

  • Change from baseline visual analog scale (VAS) wrist pain at 4th and 12th week

    Pain intensity was assessed using a visual analogue scale for pain, ranging from 0 to 10 mm, where 0 indicates the absence of pain and 10 signifies intense pain. This scale is widely recognized for its strong reliability and validity in measuring musculoskeletal pain.

    baseline and 12th week

Secondary Outcomes (5)

  • Change from baseline Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 4th and 12th week

    baseline and 12th week

  • Change from baseline Cross-sectional area of the Median Nerve (CSA) at 4th and 12th week

    baseline and 12th week

  • Change from baseline Electrophysiological Evaluation at 4th and 12th week

    baseline and 12th week

  • Change from baseline Hand Grip Strength Assessment at 4th and 12th week

    baseline and 12th week

  • Change from baseline Finger Grip Strength Assessment at 4th and 12th week

    baseline and 12th week

Study Arms (2)

Minimal Incision Surgery for median nerve decompression

ACTIVE COMPARATOR

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

Procedure: Minimal Incision Surgery for median nerve decompression

Ultrasound-guided perineural injection with 5 cc 5% Dextrose

EXPERIMENTAL

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.

Procedure: Ultrasound-guided perineural injection with 5 cc 5% Dextrose

Interventions

Minimal Incision Surgery for median nerve decompressionPROCEDURE

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

Minimal Incision Surgery for median nerve decompression
Ultrasound-guided perineural injection with 5 cc 5% DextrosePROCEDURE

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.

Ultrasound-guided perineural injection with 5 cc 5% Dextrose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 36980446BACKGROUND

  • 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.

    PMID: 34065073BACKGROUND

  • 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.

    PMID: 36686281BACKGROUND

MeSH Terms

Conditions

Musculoskeletal DiseasesMedian NeuropathyCarpal Tunnel Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Nuran EYVAZ, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

  • Ali İzzet AKÇİN, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali İzzet AKÇİN, MD

CONTACT

+905469347374dr.akcin93@gmail.com

Nuran EYVAZ, MD

CONTACT

+905334262442n_eyvaz@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Profesor

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 6, 2024

Study Start

January 25, 2024

Primary Completion

April 24, 2026

Study Completion (Estimated)

May 24, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

TU(1)