- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718598
Carpal Tunnel Syndrome in Pregnant Women
Effectiveness of Home Exercise in Pregnant Women With Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9671 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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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