The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome

Sponsor
Mardin Artuklu University (Other)
Overall Status
Completed
CT.gov ID
NCT06131996
Collaborator
(none)
41
1
2
10.9
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Volar supported splint
  • Other: elastic splint
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Volar-assisted splint group

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
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.

Active Comparator: Elastic splint group

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mardin Artuklu University Mardin Turkey

Sponsors and Collaborators

  • Mardin Artuklu University

Investigators

  • Study Director: Funda CAVUS, MARDİN ARTUKLU UNİVERSİTY, VOCATIONAL SCHOOL OF HEALTH SERVICES,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Funda Mete Cavus, Principal Investigator, Mardin Artuklu University
ClinicalTrials.gov Identifier:
NCT06131996
Other Study ID Numbers:
  • 2021/007
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023