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Completed

NCT Number: NCT06131996

The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

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

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Pregnancy Related Splints Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Artuklu University

Mardin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volar supported splint

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

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

Primary outcomes

  1. Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)

    Time frame: 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.

  2. The Boston Questionnaire (BA)

    Time frame: 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.

  3. Grip strength

    Time frame: 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.

  4. Volumetric measurement

    Time frame: 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.

  5. Visual Analog Scale (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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