Carpal Tunnel Syndrome PregnancyNCT06375291
Pregnancy-Related Carpal Tunnel Syndrome Treatment
An observational study of Carpal Tunnel Syndrome Pregnancy, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome Pregnancy
- What is being tested?
- splint /steroid injection/both
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Mar 2024
- 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 35 years
- Women only
- Adult
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.
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome Pregnancy
- Being tested
- splint /steroid injection/both
- Keywords
- carpal tunnel syndrome, pregnancy, steroid injection, ultrasound guided, splinting, Boston Carpal Tunnel Questionneaire, postpartum depression
- Medical subject headings
- Carpal Tunnel Syndrome, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splint /steroid injection/bothOther
pregnant women treated in pain department by splint /steroid injection/both
| Study group | Role | What they receive |
|---|---|---|
| 1: Steroid injected | The pregnant women with steroid injection Receives: Other: splint /steroid injection/both | |
| 2: splint | The pregnant women with splinting Receives: Other: splint /steroid injection/both | |
| 3:both | The pregnant women with steroid injection and splinting Receives: Other: splint /steroid injection/both |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
Measured: Before the intervention and 1. month, 3. months after the intervention
Secondary outcomes (2)
function severity
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
Measured: Before the intervention and 1. month, 3. months after the intervention
pregnancy and postpartum depression
assesed by Edinburg Depression Scale
Measured: Before the intervention and 1. month, 3. months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome PregnancyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Suna Aşkın Turan, Mersin Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375291
- Sponsor's protocol ID
- MersinTRHpregcts
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Data and materials are available from the corresponding author upon reasonable request and are subject to ethical review.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which is More Effective for Pregnancy-Related Carpal Tunnel Syndrome? Ultrasound Guided Steroid İnjection, Splint, or Both
- ClinicalTrials.gov ID
- NCT06375291
- Acronym / sponsor ID
- MersinTRHpregcts
- Conditions
- Carpal Tunnel Syndrome Pregnancy
- Keywords
- carpal tunnel syndrome, pregnancy, steroid injection, ultrasound guided, splinting, Boston Carpal Tunnel Questionneaire, postpartum depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mersin Training and Research HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 19 Apr 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Steroid injected | – | Other: splint /steroid injection/bothThe pregnant women with steroid injection |
| 2: splint | – | Other: splint /steroid injection/bothThe pregnant women with splinting |
| 3:both | – | Other: splint /steroid injection/bothThe pregnant women with steroid injection and splinting |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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.
- -
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 |
|---|---|---|
| splint /steroid injection/bothpregnant women treated in pain department by splint /steroid injection/both | Other | 1: Steroid injected, 2: splint, 3:both |
Primary outcome
Symptom severity
Time frame: Before the intervention and 1. month, 3. months after the intervention
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity
2 secondary outcomes
function severity
Time frame: 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
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 22 Apr 2024.
- Individual participant dataSharing planned: No. The Data and materials are available from the corresponding author upon reasonable request and are subject to ethical review.
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 Syndrome Pregnancy, run by Mersin Training and Research Hospital 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 3 inclusion and 2 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 22 Apr 2024. 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?
Symptom severity (time frame: Before the intervention and 1. month, 3. months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2024.