Clinical trial NCT06375291: Pregnancy-Related Carpal Tunnel Syndrome Treatment
Official title: Which is More Effective for Pregnancy-Related Carpal Tunnel Syndrome? Ultrasound Guided Steroid İnjection, Splint, or Both
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome Pregnancy
Keywords: carpal tunnel syndrome
pregnancy
steroid injection
ultrasound guided
splinting
Boston Carpal Tunnel Questionneaire
postpartum depression
Lead sponsor: Mersin Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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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Primary outcomes:
measure: Symptom severity
timeFrame: Before the intervention and 1. month, 3. months after the intervention
Secondary outcomes:
measure: function severity
timeFrame: Before the intervention and 1. month, 3. months after the intervention
measure: pregnancy and postpartum depression
timeFrame: Before the intervention and 1. month, 3. months after the intervention
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Suna Aşkın Turan
state: Yenişehir
Study officials:
References: