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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

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