NCT06375291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

April 11, 2024

Last Update Submit

April 19, 2024

Conditions

Keywords

carpal tunnel syndromepregnancysteroid injectionultrasound guidedsplintingBoston Carpal Tunnel Questionneairepostpartum depression

Outcome Measures

Primary Outcomes (1)

  • Symptom severity

    Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity

    Before the intervention and 1. month, 3. months after the intervention

Secondary Outcomes (2)

  • function severity

    Before the intervention and 1. month, 3. months after the intervention

  • pregnancy and postpartum depression

    Before the intervention and 1. month, 3. months after the intervention

Study Arms (3)

1: Steroid injected

The pregnant women with steroid injection

Other: splint /steroid injection/both

2: splint

The pregnant women with splinting

Other: splint /steroid injection/both

3:both

The pregnant women with steroid injection and splinting

Other: splint /steroid injection/both

Interventions

pregnant women treated in pain department by splint /steroid injection/both

1: Steroid injected2: splint3:both

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suna Aşkın Turan

Mersin, Yenişehir, 33020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeDepression, Postpartum

Interventions

Splints

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator, Pain Department Physician

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 19, 2024

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

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

Locations