The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Pregnancy Related; Splints; Carpal Tunnel Syndrome
• Interventions: Other: elastic splint; Other: Volar supported splint

• Registration Number: NCT06131996
• Lead Sponsor: Mardin Artuklu University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elastic splint group	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.
Volar-assisted splint group	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.

Primary Outcome Measures

Name	Time	Method
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)	before intervention and 4 weeks after intervention	Q-DASH questionnaire is applied to evaluate upper extremity-related functionality and symptoms. Each item provides 5 response options and the overall score is calculated from the item scores. 0, no loss of function; 100 is interpreted as the most severe loss of function.
The Boston Questionnaire (BA)	before intervention and 4 weeks after intervention	The Boston Questionnaire (BA) is specific to Carpal Tunnel Syndrome (CTS) and consists of two different scales that evaluate symptom severity and functional capacity.The scoring of each item varies between 1 and 5. The average score is obtained by dividing the total score by the number of items and ranges from 1 to 5. A high score indicates low functional capacity. Mean scores are calculated separately for symptom severity and functional capacity. The symptom score consists of 11 items and the function score consists of 8 items.
Grip strength	before intervention and 4 weeks after intervention	Grip strength was measured with the Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and whose validity and reliability have been confirmed in many studies.According to the measurement procedure, three repeated measurements were made for hand grip strength and the results were recorded in kilograms.
Volumetric measurement	before intervention and 4 weeks after intervention	The water flooding method, which is considered the gold standard in the measurement of extremity volume and is preferred in the evaluation of edematous hand or foot volume, was used in this study.With this measurement method, the amount of overflowing water volume between the affected and unaffected extremities was compared and the amount of edema was determined.
Visual Analog Scale (VAS)	before intervention and 4 weeks after intervention	The pain levels were measured by the Visual Analog Scale (VAS).It is scored between 0-10 cm. A high score indicates high pain.

Trial Locations

Locations (1)

Mardin Artuklu University; 🇹🇷 Mardin, Turkey