A Phase 4 interventional study of Carpal Tunnel Hydrodissection with %5 dextrose in water injection in Carpal Tunnel Syndrome, sponsored by Kastamonu University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Kastamonu University · Phase 4, Interventional, and Treatment
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 140 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Kastamonu University is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Mild Carpal Tunnel syndrome
Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection
Moderate Carpal Tunnel Syndrome
Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection
Severe Carpal Tunnel Syndrome
Drug: Carpal Tunnel Hydrodissection with %5 dextrose in water injection
Under the inplane ulnar approach, 3ml injectate was injected to hydrodissect the median nerve from the flexor retinaculum, and the residual 2ml injectate was then injected to hydrodissect the inferior median nerve away from the flexor tendons.
Visual Analogue Scale(VAS)
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.
Time frame: At the beginning, 1.,4., 12. week
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
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.
Time frame: At the beginning, 1.,4., 12. week
Dolour Neuropathique en 4 Questions (DN4) questionnaire
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.
Time frame: At the beginning, 1.,4., 12. week
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Kastamonu University