NCT06360510

Brief Summary

The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
Last Updated

February 23, 2026

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 7, 2024

Last Update Submit

February 19, 2026

Conditions

Keywords

carpal tunnel syndromebetamethasone% 5 dextrose

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale - 10

    The Numeric Rating Scale (NRS) is a simple and widely used tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, where: 0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-9 = Severe pain 10 = Worst pain imaginable The patient selects the number that best represents their pain at last one week

    three months

Secondary Outcomes (5)

  • boston carpal tunnel syndrome questionnaire

    three months

  • median nerve cross sectional area

    three months

  • tinnel test positivity

    three months

  • phalen test positivity

    three months

  • DuruÖz hand index

    three months

Study Arms (2)

%5 dextrose group

Procedure: %5 dextrose injection

betamethasone group

Procedure: betamethasone injection

Interventions

hydrodissection with %5 dextrose

%5 dextrose group

perineural betamethasone injection

betamethasone group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients that have carpal tunnel syndrome

You may qualify if:

  • Paresthesia and pain symptoms in the region corresponding to the distribution of the median nerve
  • Detection of mild or moderate CTS by electromyography
  • One or both of the Phalen test and/or Tinel sign are positive on physical examination
  • Symptoms have persisted for at least 3 months

You may not qualify if:

  • Those diagnosed with polyneuropathy, plexopathy, radiculopathy, thoracic outlet syndrome
  • Having had surgery or any injection for carpal tunnel syndrome within the last year
  • History of wrist fracture
  • Those with rheumatoid arthritis, uncontrolled diabetes, gout, chronic renal failure, malignancy, active systemic infection
  • Those with cognitive impairment
  • Coagulopathy or bleeding tendency
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 7, 2024

First Posted

April 11, 2024

Study Start

May 5, 2023

Primary Completion

May 5, 2024

Study Completion

May 5, 2024

Last Updated

February 23, 2026

Record last verified: 2024-04

Locations