Evaluation of Carpal Tunnel Syndrome in Pregnancy

NCT05839769 | Completed DMC

• 1 other identifier: 88
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel; Carpal Tunnel Syndrome

Keywords

pregnancy; carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Boston Carpal Tunnel Syndrome Questionnaire

  Patients were evaluated third trimester and 1 month after the birth

Study Arms (2)

carpal tunnel syndrome in third trimester pregnant women

pregnant women who has CTS

Diagnostic Test: Evaluation of median nerve with ultrasound

healthy pregnant women in third trimester

Diagnostic Test: Evaluation of median nerve with ultrasound

Interventions

Evaluation of median nerve with ultrasound DIAGNOSTIC_TEST

ultrasound examination wrist

carpal tunnel syndrome in third trimester pregnant women; healthy pregnant women in third trimester

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

CTS in pregnancy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related 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.

  PMID: 36359465 BACKGROUND

MeSH Terms

Conditions

Median Neuropathy; Carpal Tunnel Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD / Principal Investigator

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 3, 2023
• Study Start: April 10, 2023
• Primary Completion: July 10, 2023
• Study Completion: September 10, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

TU (1)