The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

NCT06131996 | Completed

• 1 other identifier: 2021/007
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Pregnancy Related; Splints

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Volar-assisted splint group

ACTIVE COMPARATOR

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.

Other: Volar supported splint

Elastic splint group

ACTIVE COMPARATOR

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

Other: elastic splint

Interventions

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.

Volar-assisted splint group

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

Elastic splint group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals who are pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mardin Artuklu University: lead

Study Sites (1)

Mardin Artuklu University

Mardin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Funda CAVUS

  MARDİN ARTUKLU UNİVERSİTY, VOCATIONAL SCHOOL OF HEALTH SERVICES,

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 15, 2023
• Study Start: February 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 30, 2022
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)