ClinicalTrials.gg
CompletedNCT03166033Updated May 24, 2017

Case-control Study on Individual Risk Factors of CTS

An observational study in Carpal Tunnel Syndrome, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 41 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-24.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
6,048
Ages
41 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Carpal Tunnel Syndrome

Keywords

  • Carpal Tunnel Syndrome
  • etiology
  • risk factor
03

In context

Carpal Tunnel Syndrome

605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.

This study's enrollment of 6,048 is above the median of 91 across 130 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
41 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • with the symptom "numbness"
  • clinical and neural-electrophysiological diagnosed CTS

Exclusion criteria

Exclusion Criteria:

  • suffered from other diseases that could cause "numbness" diagnosed clinically
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
6,048 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Other: the disease

Interventions

  • Otherthe disease

    Observation the patients and non-patients

06

What researchers measure

Primary outcomes

  1. general risk factors

    Gender, age, smoking, wrist injury, diabetes mellitus, hypothyroidism and wrist working are all the risk factors of carpal tunnel syndrome.

    Time frame: 2014-2015

07

Study locations

1 site
  • Huashan Hospital
    Shanghai, Shanghai Municipality 200040, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2013 to primary completion in Dec 2014, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2017
First posted
May 24, 2017
StartActual
Jan 1, 2013
Primary completionActual
Dec 31, 2014
CompletionActual
Apr 1, 2015
Last update
May 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03166033
Lead sponsor
Fudan University
Collaborators
National Natural Science Foundation of China
Responsible party
Guan Wenjie (Dr., Fudan University) — Principal investigator
First posted
May 24, 2017
Start date
Jan 1, 2013
Primary completion
Dec 31, 2014
Completion
Apr 1, 2015
Last update
May 24, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion