The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

Pregnancy Related Clinical Trial

Official title:

Comparison of the Effects of Volar-assisted and Elastic Wrist Splints on Edema, Pain, Grip Strength and Functionality in Pregnant Women With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131996
• Other study ID #: 2021/007
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2023
• Source: Mardin Artuklu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 30, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pregnancy Related
• Splints
• Syndrome

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
Turkey	Mardin Artuklu University	Mardin

Sponsors (1)

Lead Sponsor	Collaborator
Mardin Artuklu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)	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.	before intervention and 4 weeks after intervention
Primary	The Boston Questionnaire (BA)	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.	before intervention and 4 weeks after intervention
Primary	Grip strength	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.	before intervention and 4 weeks after intervention
Primary	Volumetric measurement	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.	before intervention and 4 weeks after intervention
Primary	Visual Analog Scale (VAS)	The pain levels were measured by the Visual Analog Scale (VAS).It is scored between 0-10 cm. A high score indicates high pain.	before intervention and 4 weeks after intervention