- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06375291
Pregnancy-Related Carpal Tunnel Syndrome Treatment
Which is More Effective for Pregnancy-Related Carpal Tunnel Syndrome? Ultrasound Guided Steroid İnjection, Splint, or Both
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy-related carpal tunnel syndrome (PRCTS) is the most frequent mononeuropathy during pregnancy. During pregnancy there is fluid retention, which leads to edema on the ligaments that form the roof of the tunnel this leads to nerve compression. PRCTS is usually bilateral and mostly develops in the third trimester of pregnancy when body fluid retention and weight gain reach the maximum. The developed PRCTS in the first or second trimester usually aggravates in the third trimester.
Pregnancy-related CTS usually has a benign prognosis. In a systematic review study conducted by Padua et al., >50% of the patients reported that the symptoms persisted even after one year of treatment, and approximately 30% of the patients still had the symptoms after three years.
Activity modification, edema control, and wrist splinting keep the wrist in a neutral position and provide symptomatic relief of PRCTS. Steroid injection may provide temporary symptom relief in many patients. Surgery is seldom indicated; however, it may be considered when the symptoms and functional impairments are severe, nonsurgical treatments are ineffective, and significant nerve compression is detected in the electrophysiological study.
The most frequent indication related to corticosteroid therapy is acute CTS, developed in the third trimester. Many studies showed the effectiveness of steroid injection on PRCTS assessed by the Boston Carpal Tunnel Questionnaire and electrophysiological results. However, when assessing physical health problems in general, and in pregnant women in particular, it is important to be aware of mental health problems. Patients who report chronic pain also experience problems in a range of psychological domains, such as depression, anxiety, and general emotional functioning. It was found that higher postpartum depression scores were related to persistent CTS symptoms at 12 months postpartum.
Splinting is an effective method for both pregnant and nonpregnant CTS usually given as a first-line therapy. In nonpregnant populations with CTS, ultrasound-guided steroid injection with splinting was found more effective than injection or splinting alone. But there is no literature on pregnant women searching the efficacy of splinting, steroid injection or both. The current study aimed to compare the effectiveness of local steroid injection plus splinting with that of local steroid injection or splinting alone for symptom severity. The secondary aim was the efficacy of the treatment on the patient's function severity and depression. Boston Carpal Tunnel Symptom Severity Scale assessed the primary outcome. Boston Carpal Tunnel Functional Severity Scale and Edinburgh Depression Scale assessed the secondary outcome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Yenişehir
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Mersin, Yenişehir, Turkey, 33020
- Suna Aşkın Turan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All pregnant women in the third trimester treated for mild to moderate PRCTS in the Pain Department between 1 January 2021 and 1 March 2023 and followed up in the first month of the postpartum period were included in the study.
All the patients were diagnosed by clinical findings and electrophysiological studies.
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Exclusion Criteria:
Patients with a lack of data, or secondary causes like as diabetes mellitus, gestational diabetes mellitus, eclampsia, preeclampsia, thyroid disorders, arthropathies, trauma to the hand or wrist, cervical disc pathology, and prior history of CTS (such as recurrence or a CTS diagnosis before pregnancy) were excluded.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1: Steroid injected
The pregnant women with steroid injection
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pregnant women treated in pain department by splint /steroid injection/both
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2: splint
The pregnant women with splinting
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pregnant women treated in pain department by splint /steroid injection/both
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3:both
The pregnant women with steroid injection and splinting
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pregnant women treated in pain department by splint /steroid injection/both
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Symptom severity
Time Frame: Before the intervention and 1. month, 3. months after the intervention
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Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
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Before the intervention and 1. month, 3. months after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
function severity
Time Frame: Before the intervention and 1. month, 3. months after the intervention
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Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
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Before the intervention and 1. month, 3. months after the intervention
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pregnancy and postpartum depression
Time Frame: Before the intervention and 1. month, 3. months after the intervention
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assesed by Edinburg Depression Scale
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Before the intervention and 1. month, 3. months after the intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MersinTRHpregcts
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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