Carpal TunnelNCT05839769
Evaluation of Carpal Tunnel Syndrome in Pregnancy
An observational study of Carpal Tunnel and Carpal Tunnel Syndrome, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel, Carpal Tunnel Syndrome
- What is being tested?
- Evaluation of median nerve with ultrasound
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 10 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: CTS in pregnancy
Who may be able to join
- 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.
Who cannot join
- a history of carpal tunnel surgery
- gestational diabetes mellitus
- eclampsia or preeclampsia
- thyroid disorders
- arthropathies, hand or wrist trauma
- bilateral fractures
Show all 14Show fewer
- atrial fibrillation
- cervical radiculopathy
- peripheral neuropathy
- thoracic outlet syndrome
- diabetes mellitus
- hypothyroidism
- hyperthyroidism
- rheumatologic disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, 34384
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Carpal Tunnel, Carpal Tunnel Syndrome
- Being tested
- Evaluation of median nerve with ultrasound
- Keywords
- pregnancy, carpal tunnel syndrome
- Medical subject headings
- Median Neuropathy, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of median nerve with ultrasoundDiagnostic test
ultrasound examination wrist
| Study group | Role | What they receive |
|---|---|---|
| carpal tunnel syndrome in third trimester pregnant women | pregnant women who has CTS Receives: Diagnostic Test: Evaluation of median nerve with ultrasound | |
| healthy pregnant women in third trimester | Not described Receives: Diagnostic Test: Evaluation of median nerve with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound imaging of wrists
Ultrasonographic measurement of the 'Nerve/Tendon Ratio' (NTR) in CTS
Measured: 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
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.
Measured: Patients were evaluated third trimester and 1 month after the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start10 Apr 2023
- Primary completion10 Jul 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal TunnelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatih sahin, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839769
- Sponsor's protocol ID
- 88
- Status last verified
- Oct 2023
- First submitted
- 18 Apr 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36359465
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Carpal Tunnel Syndrome in Pregnancy
- ClinicalTrials.gov ID
- NCT05839769
- Acronym / sponsor ID
- 88
- Conditions
- Carpal Tunnel, Carpal Tunnel Syndrome
- Keywords
- pregnancy, carpal tunnel syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carpal tunnel syndrome in third trimester pregnant women | – | Diagnostic Test: Evaluation of median nerve with ultrasoundpregnant women who has CTS |
| healthy pregnant women in third trimester | – | Diagnostic Test: Evaluation of median nerve with ultrasound |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- CTS in pregnancy
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- a history of carpal tunnel surgery
- gestational diabetes mellitus
- eclampsia or preeclampsia
- thyroid disorders
- arthropathies, hand or wrist trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of median nerve with ultrasoundultrasound examination wrist | Diagnostic test | carpal tunnel syndrome in third trimester pregnant women, healthy pregnant women in third trimester |
Primary outcome
Ultrasound imaging of wrists
Time frame: 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
Ultrasonographic measurement of the 'Nerve/Tendon Ratio' (NTR) in CTS
1 secondary outcome
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: Patients were evaluated third trimester and 1 month after the birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 36359465Falsetti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel and Carpal Tunnel Syndrome, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound imaging of wrists (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.