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The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06131996
Enrollment
41
Registered
2023-11-15
Start date
2022-02-01
Completion date
2022-12-30
Last updated
2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Pregnancy Related, Splints

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.

Interventions

OTHERVolar 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.

OTHERelastic 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

Sponsors

Mardin Artuklu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)before intervention and 4 weeks after interventionQ-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 interventionThe 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 strengthbefore intervention and 4 weeks after interventionGrip 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 measurementbefore intervention and 4 weeks after interventionThe 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 interventionThe pain levels were measured by the Visual Analog Scale (VAS).It is scored between 0-10 cm. A high score indicates high pain.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026