Carpal Tunnel SyndromeSTIF-CTSNCT01081860
Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to Dec 2010
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients presenting with complaints of: * Carpal tunnel syndrome * Trigger finger * Dupuytren contracture * an acute trauma to the hand
Who may be able to join
- Caucasian
- Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand
Who cannot join
- Hypo-/hyperthyroidism
- Diabetes
- Arthritis
- Pregnancy
- Obesity (BMI >30)
- Anatomical anomalies
Trial locations and contacts
1 site in 1 country.
Bo Verwer contact
Netherlands1 site
St Antonius Hospital
Nieuwegein, Utrecht, 3430EM
Bo Verwer, b.verwer@antoniusziekenhuis.nl
About this study
Official title: Correlation of Joint Stiffness and Stiffness of the Skin and the Prevelation of Carpal Tunnel Syndrome (CTS)
The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve.
The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal tunnel will rise more quickly in stiff patients resulting in CTS-complaints.
A relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, CTS, Skinstiffness, Jointstiffness
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Carpal tunnel syndrome | Patients with carpal tunnel syndrome | |
| Trigger finger | Patients with trigger fingers | |
| Dupuytren Contracture | Patients with Dupuytren | |
| Trauma to the hand | Patients with an acute trauma to the hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint stiffness
The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.
Measured: In the 1st month
Stiffness of the skin
Skinstiffness is measured with a suction cup
Measured: in the 1st month
Secondary outcomes (1)
Physical activities
Boston Questionairre
Measured: In the 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
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.
- 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Investigators
- A.B. Mink van der Molen, dr., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081860
- Sponsor's protocol ID
- STIF CTS
- Acronym
- STIF-CTS
- Status last verified
- Apr 2010
- First submitted
- 2 Mar 2010
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Joint Stiffness and Stiffness of the Skin and the Prevelation of Carpal Tunnel Syndrome (CTS)
- ClinicalTrials.gov ID
- NCT01081860
- Acronym / sponsor ID
- STIF-CTS / STIF CTS
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, CTS, Skinstiffness, Jointstiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 5 Mar 2010 (estimated)
- 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 exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve.
The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal tunnel will rise more quickly in stiff patients resulting in CTS-complaints.
A relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Carpal tunnel syndrome | – | –Patients with carpal tunnel syndrome |
| Trigger finger | – | –Patients with trigger fingers |
| Dupuytren Contracture | – | –Patients with Dupuytren |
| Trauma to the hand | – | –Patients with an acute trauma to the hand |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients presenting with complaints of: * Carpal tunnel syndrome * Trigger finger * Dupuytren contracture * an acute trauma to the hand
Key inclusion criteria (2 listed)
- Caucasian
- Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand
Key exclusion criteria (6 listed)
- Hypo-/hyperthyroidism
- Diabetes
- Arthritis
- Pregnancy
- Obesity (BMI >30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Joint stiffness
Time frame: In the 1st month
The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.
Stiffness of the skin
Time frame: in the 1st month
Skinstiffness is measured with a suction cup
1 secondary outcome
Physical activities
Time frame: In the 1st month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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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.
Bo Verwer contact
A.B. Mink van der Molen, dr. principal investigator
St. Antonius Hospital
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 St. Antonius Hospital at 1 site in Netherlands.
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 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2010. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Verwer (b.verwer@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint stiffness (time frame: In the 1st month). The study lists 2 primary outcomes in all. 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 27 Apr 2010.