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NCT06360510 Clinical Trial

Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:
Comparison of the Effectiveness of Ultrasound-guided 5% Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06360510
Other study ID # 44
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 5, 2023
Est. completion date May 5, 2024

Study information
Verified date April 2024
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Description:

It is planned as an observational, single-center clinical study.A total of 28 patients diagnosed with mild-moderate carpal tunnel syndrome who meet the inclusion criteria will be included in the study.Patients who had been experiencing trigger finger symptoms for at least three month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine. Patients will be divided into two groups. One group will receive 5% dextrose, the other group will receive 1 session of local injection by mixing Celeston chronodose [1ml/3 mg betamethasone acetate+3,947 mg betamethasone disodium phosphate (equivalent to 3 mg betamethasone)] and 1 ml 2% prilocaine. Evaluations will be made before injection, at weeks 4 and 12.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date May 5, 2024
Est. primary completion date May 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• %5 dextrose injection
hydrodissection with %5 dextrose
• betamethasone injection
perineural betamethasone injection

Locations
Country Name City State
Turkey Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary vas three months
Secondary boston carpal tunnel syndrome questionnaire three months
Secondary median nerve cross sectional area three months
Secondary tinnel test positivity three months
Secondary phalen test positivity three months
Secondary duruöz hand index three months
Secondary global evaluation of treatment outcomes three months
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