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

Active, not recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: %5 dextrose injection; Procedure: betamethasone injection

• Registration Number: NCT06360510
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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).

Detailed 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.

Study Timeline

• Study Start: 2023-05-05
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Last Update Submitted: 2024-04-07
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-05-05
• Study Completion: 2024-05-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
%5 dextrose group	%5 dextrose injection	-
betamethasone group	betamethasone injection	-

Primary Outcome Measures

Name	Time	Method
vas	three months

Secondary Outcome Measures

Name	Time	Method
boston carpal tunnel syndrome questionnaire	three months
duruöz hand index	three months
global evaluation of treatment outcomes	three months
tinnel test positivity	three months
median nerve cross sectional area	three months
phalen test positivity	three months

Trial Locations

Locations (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey