Evaluation of Carpal Tunnel Syndrome in Pregnancy

Carpal Tunnel Syndrome Clinical Trial

Official title:

Evaluation of Carpal Tunnel Syndrome in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839769
• Other study ID #: 88
• Status: Completed
• Start date: April 10, 2023
• Est. completion date: September 10, 2023

Study information

• Verified date: October 2023
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Carpal tunnel syndrome (CTS) is a condition that arises due to the compression of the median nerve in the carpal tunnel of the wrist. The prevalence of CTS in the general population is estimated to be between 3% and 6%, with higher rates in certain occupations or activities that involve repetitive hand movements or vibrations. During pregnancy, CTS can be particularly important due to hormonal changes that can cause an increase in fluid retention and pressure on the median nerve. The prevalence of CTS during pregnancy varies widely in the literature, with some studies reporting rates as high as 45%. Ultrasound is a non-invasive imaging technique that can be used to diagnose CTS by measuring the cross-sectional area of the median nerve. While there is some debate regarding the normative values of median nerve cross-sectional area, ultrasound is generally considered a reliable diagnostic tool for CTS. Previous research has utilized ultrasound to measure the cross-sectional area of the median nerve (MN-CSA) in pregnant women diagnosed with carpal tunnel syndrome (CTS). However, the potential diagnostic value of the MN-CSA/flexor carpi radialis cross-sectional area (FCR-CSA) ratio has not been examined in this population. Given that edema, a common symptom of pregnancy, may affect MN-CSA but not MN-CSA/FCR-CSA ratio, this novel ultrasound parameter may offer superior sensitivity for diagnosing CTS in pregnant women.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Evaluation of median nerve with ultrasound
ultrasound examination wrist

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

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