The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

NCT ID: NCT06131996

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-12-30

Brief Summary

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It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use.

Detailed Description

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Carpal tunnel syndrome (CTS) is a common musculoskeletal problem in pregnancy. The aim of this study is to compare the effects of rigid and elastic wrist splints on edema, pain levels, grip strength, and upper extremity functionality in pregnant women with CTS.

Pregnant women in the last trimester of pregnancy who were diagnosed with CTS were included in the study.

Conditions

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Carpal Tunnel Syndrome Pregnancy Related Splints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Volar-assisted splint group

Participants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week.

Group Type ACTIVE_COMPARATOR

Volar supported splint

Intervention Type OTHER

participants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week.

Elastic splint group

Participants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week.

Group Type ACTIVE_COMPARATOR

elastic splint

Intervention Type OTHER

participants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week

Interventions

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Volar supported splint

participants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week.

Intervention Type OTHER

elastic splint

participants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being in the last trimester of pregnancy,
* Having a diagnosis of CTS,
* Positive Tinnel and Phalen tests,
* Pain, tenderness, and numbness symptoms in the median nerve neurodynamic test,
* pain of at least 4 severity according to VAS,
* Edema due to pregnancy

Exclusion Criteria

* Individuals in the 1st or 2nd trimester of pregnancy,
* Those with pain complaints below 4 according to VAS,
* Those with a history of CTS before pregnancy,
* Those who had undergone surgery in the hand-wrist region
* Those diagnosed with cervical disc herniation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mardin Artuklu University

OTHER

Sponsor Role lead

Responsible Party

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Funda Mete Cavus

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Funda CAVUS

Role: STUDY_DIRECTOR

MARDİN ARTUKLU UNİVERSİTY, VOCATIONAL SCHOOL OF HEALTH SERVICES,

Locations

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Mardin Artuklu University

Mardin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021/007

Identifier Type: -

Identifier Source: org_study_id

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