Carpal Tunnel Syndrome in Pregnant Women

October 26, 2018 updated by: Bezmialem Vakif University

Effectiveness of Home Exercise in Pregnant Women With Carpal Tunnel Syndrome

The purpose of our study is to evaluate the effectiveness of the home exercise program in patients who develop Carpal tunnel syndrome (CTS).

Study Overview

Status

Completed

Detailed Description

Materials and Method: Thirty-three patients with CTS (mild to moderate) were included to randomized, single-blind, controlled clinical trial. Based on EMG results and clinical examination, patient group was divided two part as mild and moderate CTS (group 1) and normal (group 2). The Sick Boston Carpal Tunnel Syndrome Questionnaire form was filled in face-to-face method.

Cases in this study: Patients who had pain and numbness problems at the hands of the Bezmiâlem Vakif University Polyclinic for Women and Obstetrics were then directed to the Bezmiâlem Vakif University Physical Therapy Rehabilitation Policlinic. After the examination and clinical testing of each patient (Tinel test, Phalen's test, Reverse Phalen's and Durkan's Carpal Compression test), the patients were directed to Bezmiâlem Vakif University Neurology Policlinic. Based on electromyography (EMG) results and clinical examination, the group was classified as mild and moderate CTS (group 1) and normal (group 2). A disease exercise form was distributed for all patients to do exercises.

Study Type

Observational

Enrollment (Actual)

33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Non-Probability Sample: Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer

Description

Inclusion Criteria:

  • Provocation tests during the examination and physical examination to match the median nerve distribution those who have symptoms of numbness, tingling, weakness and pain in the hands that have lasted at least 1 month.
  • Patients with confirmed mild-moderate idiopathic CTS on EMG.

Exclusion Criteria:

  • Previously undergone carpal tunnel surgery
  • Gestational diabetes mellitus,
  • Eclampsia, preeclampsia
  • Thyroid disorders
  • Arthropathies
  • Hand or wrist trauma
  • Bilateral fractures
  • Severe cts
  • Atrial fibrillation
  • Cervical radiculopathy
  • Peripheral neuropathy
  • Thoracic outlet syndrome
  • Diabetes mellitus
  • Hypothyroidism
  • Hyperthyroidism
  • Rheumatologic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carpal tunnel syndrome
Patients with mild and moderate carpal tunnel syndrome
Tendon and Nerve Gliding Exercises: The tendon slip exercises used in this study were performed in five different positions, namely flexion, flat, hook, punch, table top and flat punch positions. Nerve-gliding exercises were performed by moving the fingers and wrists in six different positions, focusing on the median nerve consisting of all the disease grip, finger lengthening, wrist extension, thumb extension, forearm supination and gentle gentle gait. Instructions were given to make 10 sets of exercises in 3 sets, written and verbal, in order to have e exercises for all patient's tendons and nerves shifting exercises. Brochures were also provided explaining the exercises.
normal
Patients without mild and moderate carpal tunnel syndrome
Tendon and Nerve Gliding Exercises: The tendon slip exercises used in this study were performed in five different positions, namely flexion, flat, hook, punch, table top and flat punch positions. Nerve-gliding exercises were performed by moving the fingers and wrists in six different positions, focusing on the median nerve consisting of all the disease grip, finger lengthening, wrist extension, thumb extension, forearm supination and gentle gentle gait. Instructions were given to make 10 sets of exercises in 3 sets, written and verbal, in order to have e exercises for all patient's tendons and nerves shifting exercises. Brochures were also provided explaining the exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sick Boston Carpal Tunnel Syndrome Questionnaire
Time Frame: Patients were evaluated before treatment and 1 month after the birth.
It is a test consisting of two parts evaluating symptom severity (BSSS) and functional capacity (BFCS). BSSS consists of 11 questions for symptoms. In each question there are five different answers with scores between 1 and 5. The average score is obtained by dividing the total score by the number of questions. High score indicates severe symptom. BFCS consists of 8 questions for functional capacity. Again, there are five different answers in each question, ranging from 1 to 5. The average score is obtained by dividing the total score by the number of questions. The high score indicates that the functional capacity decreases. The questionnaire has been validated and tested for Turkish society (15). The questionnaire has been validated and tested for Turkish society (16).
Patients were evaluated before treatment and 1 month after the birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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