Carpal Tunnel SyndromeNCT03166033
Case-control Study on Individual Risk Factors of CTS
An observational study of Carpal Tunnel Syndrome, run by Fudan University at 1 site in China.
Trial summary
This study is conducted to observe the characteristics of the risk factors of CTS in Chinese population. Read more about this study
- Who is it for?
- Ages 41 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- the disease
- How many people
- 6,048 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 1 Apr 2015
- 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 41 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics.
Who may be able to join
- with the symptom "numbness"
- clinical and neural-electrophysiological diagnosed CTS
Who cannot join
- suffered from other diseases that could cause "numbness" diagnosed clinically
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case-control Study on Individual Risk Factors of Carpal Tunnel Syndrome
This study is conducted to observe the characteristics of the risk factors of CTS in Chinese population.
Read the detailed description
Carpal tunnel syndrome (CTS), or median neuropathy at the wrist, is a medical condition in which the median nerve is compressed at the wrist, leading to paresthesia, numbness and muscle weakness in the hand. It's the most common neuro-compressive disease. With the development of the modern life, the morbidity of CTS is also raised. As a common disease, the study on etiology is very important in Carpal Tunnel Syndrome, which can improve the life quality of patients with carpal tunnel syndrome. The risk factors include individual factors such as age, gender, diabetes, Hypothyroidism, obesity, complication of systematic diseases, tobacco, injury and occupational factors.
As most of the research were based on the population in western country and the life style and the ethnicity between Chinese people and western country people is quite different, there may be some similarities and differences in epidemiology. There is seldom similar research in China so that this study was conducted to observe the characteristics of these risk factors in Chinese population.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- the disease
- Keywords
- Carpal Tunnel Syndrome, etiology, risk factor
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the diseaseOther
Observation the patients and non-patients
| Study group | Role | What they receive |
|---|---|---|
| Case Group | age between 41 and 70years. People in the case group with the symptom "numbness" and then were clinical and neural-electrophysiological diagnosed CTS. People in the control group would be exclude the symptom "numbness". The case group included clinical diagnosed carpal tunnel syndrome which was divided into 4 parts every 10 years old age. The gender of the patients of the control group was matched to the case group and divided into 4 parts by age. Receives: Other: the disease | |
| Control Group | The present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics. Both groups filled out a standardized questionnaire, and a standardized patient record was filled out by a hand surgeon. In addition, participants with jobs involving lifting and carrying of loads were interviewed. Receives: Other: the disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
general risk factors
Gender, age, smoking, wrist injury, diabetes mellitus, hypothyroidism and wrist working are all the risk factors of carpal tunnel syndrome.
Measured: 2014-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jan 2013
- Primary completion31 Dec 2014
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Retrospective
- Enrolment
- 6,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Guan Wenjie, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166033
- Sponsor's protocol ID
- 81572127
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao KM, Hu JJ, Lao J, Zhao X. Evaluation of nerve transfer options for treating total brachial plexus avulsion injury: A retrospective study of 73 participants. Neural Regen Res. 2018 Mar;13(3):470-476. doi: 10.4103/1673-5374.228730.
PubMed 29623932
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study on Individual Risk Factors of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03166033
- Acronym / sponsor ID
- 81572127
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, etiology, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,048 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 24 May 2017 (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.
This study is conducted to observe the characteristics of the risk factors of CTS in Chinese population.
Detailed description
Carpal tunnel syndrome (CTS), or median neuropathy at the wrist, is a medical condition in which the median nerve is compressed at the wrist, leading to paresthesia, numbness and muscle weakness in the hand. It's the most common neuro-compressive disease. With the development of the modern life, the morbidity of CTS is also raised. As a common disease, the study on etiology is very important in Carpal Tunnel Syndrome, which can improve the life quality of patients with carpal tunnel syndrome. The risk factors include individual factors such as age, gender, diabetes, Hypothyroidism, obesity, complication of systematic diseases, tobacco, injury and occupational factors.
As most of the research were based on the population in western country and the life style and the ethnicity between Chinese people and western country people is quite different, there may be some similarities and differences in epidemiology. There is seldom similar research in China so that this study was conducted to observe the characteristics of these risk factors in Chinese population.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: the diseaseage between 41 and 70years. People in the case group with the symptom "numbness" and then were clinical and neural-electrophysiological diagnosed CTS. People in the control group would be exclude the symptom "numbness". The case group included clinical diagnosed carpal tunnel syndrome which was divided into 4 parts every 10 years old age. The gender of the patients of the control group was matched to the case group and divided into 4 parts by age. |
| Control Group | – | Other: the diseaseThe present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics. Both groups filled out a standardized questionnaire, and a standardized patient record was filled out by a hand surgeon. In addition, participants with jobs involving lifting and carrying of loads were interviewed. |
Who may qualify
- Ages
- 41 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics.
Key inclusion criteria (2 listed)
- with the symptom "numbness"
- clinical and neural-electrophysiological diagnosed CTS
Key exclusion criteria (1 listed)
- suffered from other diseases that could cause "numbness" diagnosed clinically
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 |
|---|---|---|
| the diseaseObservation the patients and non-patients | Other | Case Group, Control Group |
Primary outcome
general risk factors
Time frame: 2014-2015
Gender, age, smoking, wrist injury, diabetes mellitus, hypothyroidism and wrist working are all the risk factors of carpal tunnel syndrome.
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 24 May 2017.
- Derived from this study: PubMed 29623932Gao KM, Hu JJ, Lao J, Zhao X. Evaluation of nerve transfer options for treating total brachial plexus avulsion injury: A retrospective study of 73 participants. Neural Regen Res. 2018 Mar;13(3):470-476. doi: 10.4103/1673-5374.228730.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Fudan University at 1 site in China.
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 1 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
general risk factors (time frame: 2014-2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166033, which also lists 1 linked publication.
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 24 May 2017.