Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome

Phase 4

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection

• Registration Number: NCT06349265
• Lead Sponsor: Kastamonu University

Brief Summary

This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-02
• Primary Completion: 2024-02-02
• Status Verified: 2024-03
• Study Completion: 2024-03-02
• Study First Submitted: 2024-03-31
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
2. Sensory loss with numbness in the median nerve-innervated regions of the hand.
3. Weakness with atrophy of the median nerve-innervated thenar muscles.
4. Positive Phalen's test and/or Tinel's sign.
5. The diagnosis should be confirmed with electrodiagnostic studies.

Exclusion Criteria

1. History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
2. History of systematic infection, and rheumatologic disorders.
3. Previous steroid injection for carpal tunnel syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Carpal Tunnel Hydrodissection with %5 dextrose in water injection	Mild Carpal Tunnel syndrome
Group 2	Carpal Tunnel Hydrodissection with %5 dextrose in water injection	Moderate Carpal Tunnel Syndrome
Group 3	Carpal Tunnel Hydrodissection with %5 dextrose in water injection	Severe Carpal Tunnel Syndrome

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale(VAS)	At the beginning, 1.,4., 12. week	VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line. The Turkish version of the assessment has been validated and shown to be reliable.

Secondary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)	At the beginning, 1.,4., 12. week	The Boston Carpal Tunnel Questionnaire (BCTQ) comprises two subscales. The Symptom Severity Scale provides data on symptom intensity, while the Functional Status Scale assesses hand function. The Symptom Severity Scale comprises 11 items evaluating pain, paresthesia, numbness, weakness, night symptoms, and difficulty grasping. Meanwhile, the Functional Status Scale includes eight items assessing functional deficits in writing, buttoning clothes, holding a book while reading, gripping a phone handle, opening jars, performing household chores, carrying a shopping bag, bathing, and dressing.; Each item is scored from 1 (no symptoms/no difficulty) to 5 (worst symptom or cannot perform the activity at all). The average score of each scale yields a score between 1 and 5, with higher scores indicating more severe symptoms or functional impairments.A Turkish validity and reliability study has been conducted.
Dolour Neuropathique en 4 Questions (DN4) questionnaire	At the beginning, 1.,4., 12. week	The DN4 (Dolour Neuropathique en 4 Questions) questionnaire is a screening tool designed to aid in diagnosing neuropathic pain. Developed in 2005, it consists of ten items, with seven questions focusing on sensory symptoms and three on signs related to neuropathic pain. The questions cover various characteristics of neuropathic pain, such as burning, tingling, and sensitivity to touch. Turkish validity and reliability measures were established for its use.

Trial Locations

Locations (1)

Gamze Gül Güleç; 🇹🇷 Kastamonu, Turkey