Pregnancy-Related Carpal Tunnel Syndrome Treatment

April 19, 2024 updated by: Suna Aşkın Turan, Mersin Training and Research Hospital

Which is More Effective for Pregnancy-Related Carpal Tunnel Syndrome? Ultrasound Guided Steroid İnjection, Splint, or Both

The current retrospective study aimed to compare the effectiveness of local steroid injection plus splinting with that of local steroid injection or splinting alone. To assess the primary outcome, The Boston Carpal Tunnel Symptom Severity Scale was used. The secondary aim was the efficacy of the treatment on the patient's function severity and depression assessed by The Boston Carpal Tunnel Symptom Function Scale Edinburgh Depression Scale.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yenişehir
      • Mersin, Yenişehir, Turkey, 33020
        • Suna Aşkın Turan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

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.

-

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1: Steroid injected
The pregnant women with steroid injection
Other: splint /steroid injection/both
pregnant women treated in pain department by splint /steroid injection/both
2: splint
The pregnant women with splinting
Other: splint /steroid injection/both
pregnant women treated in pain department by splint /steroid injection/both
3:both
The pregnant women with steroid injection and splinting
Other: splint /steroid injection/both
pregnant women treated in pain department by splint /steroid injection/both

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom severity
Time Frame: Before the intervention and 1. month, 3. months after the intervention
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
Before the intervention and 1. month, 3. months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
function severity
Time Frame: Before the intervention and 1. month, 3. months after the intervention
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
Before the intervention and 1. month, 3. months after the intervention
pregnancy and postpartum depression
Time Frame: Before the intervention and 1. month, 3. months after the intervention
assesed by Edinburg Depression Scale
Before the intervention and 1. month, 3. months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MersinTRHpregcts

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Data and materials are available from the corresponding author upon reasonable request and are subject to ethical review.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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