Carpal Tunnel SyndromeNCT03718598
Carpal Tunnel Syndrome in Pregnant Women
An observational study of Carpal Tunnel Syndrome and Exercise, run by Bezmialem Vakif University.
Trial summary
The purpose of our study is to evaluate the effectiveness of the home exercise program in patients who develop Carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome, Exercise
- What is being tested?
- Tendon and Nerve Gliding Exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Non-Probability Sample: Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer
Who may be able to join
- 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.
Who cannot join
- Previously undergone carpal tunnel surgery
- Gestational diabetes mellitus,
- Eclampsia, preeclampsia
- Thyroid disorders
- Arthropathies
- Hand or wrist trauma
Show all 16Show fewer
- Bilateral fractures
- Severe cts
- Atrial fibrillation
- Cervical radiculopathy
- Peripheral neuropathy
- Thoracic outlet syndrome
- Diabetes mellitus
- Hypothyroidism
- Hyperthyroidism
- Rheumatologic disease
About this study
Official title: 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).
Read the 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.
- Conditions
- Carpal Tunnel Syndrome, Exercise
- Being tested
- Tendon and Nerve Gliding Exercises
- Keywords
- Carpal tunnel syndrome, home exercise, pregnant women
- Medical subject headings
- Carpal Tunnel Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon and Nerve Gliding ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Carpal tunnel syndrome | Patients with mild and moderate carpal tunnel syndrome Receives: Behavioral: Tendon and Nerve Gliding Exercises | |
| normal | Patients without mild and moderate carpal tunnel syndrome Receives: Behavioral: Tendon and Nerve Gliding Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick Boston Carpal Tunnel Syndrome Questionnaire
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).
Measured: Patients were evaluated before treatment and 1 month after the birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718598
- Sponsor's protocol ID
- 9671
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home Exercise in Pregnant Women With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03718598
- Acronym / sponsor ID
- 9671
- Conditions
- Carpal Tunnel Syndrome, Exercise
- Keywords
- Carpal tunnel syndrome, home exercise, pregnant women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study is to evaluate the effectiveness of the home exercise program in patients who develop Carpal tunnel syndrome (CTS).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal tunnel syndrome | – | Behavioral: Tendon and Nerve Gliding ExercisesPatients with mild and moderate carpal tunnel syndrome |
| normal | – | Behavioral: Tendon and Nerve Gliding ExercisesPatients without mild and moderate carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Non-Probability Sample: Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- Previously undergone carpal tunnel surgery
- Gestational diabetes mellitus,
- Eclampsia, preeclampsia
- Thyroid disorders
- Arthropathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendon and Nerve Gliding ExercisesTendon 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. | Behavioural | Carpal tunnel syndrome, normal |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome and Exercise, run by Bezmialem Vakif University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick Boston Carpal Tunnel Syndrome Questionnaire (time frame: Patients were evaluated before treatment and 1 month after the birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.