Carpal Tunnel Syndrome Clinical Trial
Official title:
Evaluation of Carpal Tunnel Syndrome in Pregnancy
NCT number | NCT05839769 |
Other study ID # | 88 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 10, 2023 |
Est. completion date | September 10, 2023 |
Verified date | October 2023 |
Source | Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Carpal tunnel syndrome (CTS) is a condition that happens when the median nerve in the wrist gets compressed, causing pain, numbness, and tingling in the hand and fingers. It's a common condition that affects between 3% and 6% of people in the general population. During pregnancy, CTS can be a bigger problem because hormonal changes can cause swelling and put more pressure on the median nerve. Studies show that CTS can affect up to 45% of pregnant women, making it important to identify and manage. CTS can be diagnosed through a physical exam by a doctor, who will check for symptoms like pain, tingling, or weakness in the hand and fingers. Ultrasound can also be used to diagnose CTS by measuring the size of the median nerve in the wrist. This is a non-invasive imaging technique that is generally considered reliable for diagnosing CTS. In previous studies, ultrasound has been used to measure the size of the median nerve in pregnant women with carpal tunnel syndrome (CTS). However, a new ratio of median nerve cross-sectional area to flexor carpi radialis cross-sectional area (MN-CSA/FCR-CSA) has not been studied in pregnant women. This ratio may be a more sensitive diagnostic tool for CTS because it is not affected by swelling, which is a common symptom during pregnancy that can affect the size of the median nerve.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 10, 2023 |
Est. primary completion date | July 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - have undergone provocation tests during physical examination that match the median nerve distribution, and are experiencing symptoms of numbness, tingling, weakness and pain in the hands that have persisted for at least one month, and have been diagnosed with carpal tunnel syndrome through electromyography. Exclusion Criteria: - a history of carpal tunnel surgery - gestational diabetes mellitus - eclampsia or preeclampsia - thyroid disorders - arthropathies, hand or wrist trauma - bilateral fractures - atrial fibrillation - cervical radiculopathy - peripheral neuropathy - thoracic outlet syndrome - diabetes mellitus - hypothyroidism - hyperthyroidism - rheumatologic disease. |
Country | Name | City | State |
---|---|---|---|
Turkey | Prof. Dr. Cemil Tascioglu City Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization |
Turkey,
Falsetti P, Conticini E, Baldi C, D'Ignazio E, Al Khayyat SG, Bardelli M, Gentileschi S, D'Alessandro R, D'Alessandro M, Acciai C, Ginanneschi F, Cantarini L, Frediani B. A Novel Ultrasonographic Anthropometric-Independent Measurement of Median Nerve Swelling in Carpal Tunnel Syndrome: The "Nerve/Tendon Ratio" (NTR). Diagnostics (Basel). 2022 Oct 28;12(11):2621. doi: 10.3390/diagnostics12112621. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultrasound imaging of wrists | Ultrasonographic measurement of the 'Nerve/Tendon Ratio' (NTR) in CTS | The prospectively designed study will conclude upon reaching a sample size of 60 participants in the third trimester of pregnancy within a 3-month period | |
Secondary | Boston Carpal Tunnel Syndrome Questionnaire | The questionnaire used in this study comprises of two parts, namely the Boston Symptom Severity Scale (BSSS) and the Boston Functional Capacity Scale (BFCS). The BSSS contains 11 questions related to symptom severity, with each question having five response options scored between 1 and 5. The total score is obtained by summing up the individual scores and dividing the result by the number of questions. A higher score on this scale indicates more severe symptoms. Similarly, the BFCS consists of 8 questions assessing functional capacity, with each question also having five response options scored between 1 and 5. The total score is obtained by summing up the individual scores and dividing the result by the number of questions. A higher score on this scale indicates decreased functional capacity. It is important to note that the questionnaire has been validated and tested for use in the Turkish population. | Patients were evaluated third trimester and 1 month after the birth |
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