Comparison of the Effectiveness of Nerve Hydrodissection With Saline Injection of 5% Dextrose in Carpal Tunnel Syndrome.
Evaluation of Pain, Hand Function, Electrophysiological and Ultrasonographic Effects When Comparing 5% Dextrose Saline Injection Via Nerve Hydrodissection Under Ultrasound Guidance in Mild to Moderate Carpal Tunnel Syndrome.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey (Türkiye)
- Antalya Eğitim Araştırma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-80 years
- Clinical and electrophysiological diagnosis of mild to moderate carpal tunnel syndrome
- Symptom duration of at least 3 months
- Both male and female participants
- Patients who have not responded adequately to conservative treatment
- Patients who do not wish to undergo surgical treatment
- Ability to provide informed consent
Exclusion Criteria:
- Severe or very severe carpal tunnel syndrome based on EMG findings
- Previous injection therapy for carpal tunnel syndrome
- Prior wrist or carpal tunnel surgery
- Polyneuropathy or other peripheral neuropathies
- Cervical radiculopathy or proximal median nerve entrapment
- Brachial plexopathy or thoracic outlet syndrome
- Pregnancy
- Malignancy
- Local or systemic infection
- Cognitive impairment affecting cooperation
- Systemic diseases affecting the median nerve (e.g., uncontrolled diabetes mellitus, thyroid disorders)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: 5% dextrose group
Ultrasound-guided median nerve hydrodissection with 5% dextrose
|
Injection therapy
Other Names:
|
|
Sham Comparator: Saline group
Sham ultrasound-guided perineural injection with normal saline
|
Injection therapy
Other Names:
|
|
Sham Comparator: Splint group
Patients use only a wrist splint without injection therapy
|
Injection therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity measured by Visual Analog Scale (VAS)
Time Frame: Baseline to 8 month
|
The primary outcome is the change in pain intensity assessed by the Visual Analog Scale (VAS, 0-10).
The difference between baseline and follow-up scores will be analyzed.
|
Baseline to 8 month
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Qucik DASH score
Time Frame: Baseline to 8 month
|
Assessed using symptom severity and functional status scales
|
Baseline to 8 month
|
|
Change in median nerve cross-sectional area
Time Frame: Baseline to 8 month
|
Measured at the carpal tunnel inlet using ultrasonography
|
Baseline to 8 month
|
|
hange in nerve conduction study parameters
Time Frame: Baseline to 8 month
|
Distal motor latency and sensory conduction velocity of the median nerve
|
Baseline to 8 month
|
|
Change in hand grip strength
Time Frame: Baseline to 8 month
|
Strength of the arm
|
Baseline to 8 month
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2026528
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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