NCT05222126

Brief Summary

The aim of our study is to determine the effectiveness of US-guided hydrodissection of the median nerve in different contents and volumes in patients diagnosed with mild to moderate carpal tunnel syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

January 31, 2022

Last Update Submit

January 10, 2024

Conditions

Musculoskeletal DiseasesMedian Nerve DiseaseCarpal Tunnel SyndromeUltrasound-Guided Injection

Keywords

Carpal Tunnel SyndromeUltrasound-Guided InjectionHydrodissection

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

    up to 12th week

Secondary Outcomes (4)

  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

    up to 12th week

  • Cross-sectional area of the Median Nerve (CSA)

    up to 12th week

  • Electrophysiological Evaluation

    up to 12th week

  • Hand and Finger Grip Strength Assessment

    up to 12th week

Study Arms (4)

Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose

EXPERIMENTAL

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve using 5 cc of 5% dextrose.

Procedure: Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose

Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline

ACTIVE COMPARATOR

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve , using 5 cc normal saline.

Procedure: Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline

Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose

EXPERIMENTAL

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve , using 10 cc 5% dextrose.

Procedure: Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose

Ultrasound-guided Hydrodissection (HD) with 10 cc Normal Saline

ACTIVE COMPARATOR

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, it was planned to hydrodissect the median nerve from , using 10 cc normal saline.

Procedure: Ultrasound-guided Hydrodissection (HD) with 10 cc Normal Saline

Interventions

Ultrasound-guided Hydrodissection (HD) with 5 cc 5% DextrosePROCEDURE

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 5 cc of 5% dextrose.

Ultrasound-guided Hydrodissection (HD) with 5 cc 5% Dextrose
Ultrasound-guided Hydrodissection (HD) with 5 cc Normal SalinePROCEDURE

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 5 cc normal saline.

Ultrasound-guided Hydrodissection (HD) with 5 cc Normal Saline
Ultrasound-guided Hydrodissection (HD) with 10 cc 5% DextrosePROCEDURE

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 10 cc 5% dextrose.

Ultrasound-guided Hydrodissection (HD) with 10 cc 5% Dextrose
Ultrasound-guided Hydrodissection (HD) with 10 cc Normal SalinePROCEDURE

The median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 10 cc normal saline.

Ultrasound-guided Hydrodissection (HD) with 10 cc Normal Saline

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of symptoms of carpal tunnel syndrome, including nocturnal, postural, or movement-related paresthesias +/- pain in the median nerve distribution area in the hand for more than 3 months
  • Presence of mild to moderate carpal tunnel syndrome proven by electrophysiological study
  • Loss of sensation with numbness in the median nerve-innervated areas of the hand, weakness of the median nerve-innervated thenar muscles
  • Positive Phalen test and/or Tinel sign

You may not qualify if:

  • Patients who can mimic the diagnosis of carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
  • Patients who have had an injection into the carpal tunnel in the last 6 months
  • Patients with thenar muscle atrophy
  • History of Carpal tunnel surgery
  • Regular use of systemic nonsteroidal anti-inflammatory drugs and corticosteroids
  • Pregnancy
  • Rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, polymyositis
  • Presence of malignancy
  • Presence of active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Afyonkarahi̇sar, 03200, Turkey (Türkiye)

Location

Related Publications (4)

  • 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: 32617017BACKGROUND

  • Chang KV, Wu WT, Ozcakar L. Ultrasound imaging and guidance in peripheral nerve entrapment: hydrodissection highlighted. Pain Manag. 2020 Mar;10(2):97-106. doi: 10.2217/pmt-2019-0056. Epub 2020 Mar 12.

    PMID: 32162601BACKGROUND

  • Lam KHS, Hung CY, Chiang YP, Onishi K, Su DCJ, Clark TB, Reeves KD. Ultrasound-Guided Nerve Hydrodissection for Pain Management: Rationale, Methods, Current Literature, and Theoretical Mechanisms. J Pain Res. 2020 Aug 4;13:1957-1968. doi: 10.2147/JPR.S247208. eCollection 2020.

    PMID: 32801851BACKGROUND

  • Eyvaz N, Adar S, Akcin AI, Dundar U, Toktas H, Eroglu S. Comparison of Ultrasound-Guided Hydrodissection With Various Volumes of 5% Dextrose for Carpal Tunnel Syndrome: A Prospective Randomized Controlled Double-Blind Trial. Am J Phys Med Rehabil. 2025 Jul 1;104(7):596-604. doi: 10.1097/PHM.0000000000002675. Epub 2024 Dec 3.

    PMID: 39642354DERIVED

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Profesor

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 3, 2022

Study Start

September 20, 2022

Primary Completion

December 20, 2023

Study Completion

January 10, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations

TU(1)