Stiffness of the Skin and Joints in Relation to Carpal Tu... | NCT01081860

Studies
Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome

NCT01081860

Sponsor

St. Antonius Hospital

Status

Unknown status

Last Update Posted

Apr 27, 2010Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Carpal Tunnel Syndrome

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Nov 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Mar 2, 2010

First Submission Date that Met QC Criteria

Mar 4, 2010

First Posted Date

Mar 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2010

Last Update Posted Date

Apr 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Joint stiffness	The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.	In the 1st month
Stiffness of the skin	Skinstiffness is measured with a suction cup	in the 1st month

Secondary Outcomes

Measure	Description	Time Frame
Physical activities	Boston Questionairre	In the 1st month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian
Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand

Exclusion Criteria:

Hypo-/hyperthyroidism
Diabetes
Arthritis
Pregnancy
Obesity (BMI >30)
Anatomical anomalies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients presenting with complaints of:

Carpal tunnel syndrome
Trigger finger
Dupuytren contracture
an acute trauma to the hand

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bo Verwer	Contact			b.verwer@antoniusziekenhuis.nl

Overall Officials

Name	Affiliation	Role
A.B. Mink van der Molen, dr.	St. Antonius Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Antonius Hospital		Nieuwegein	Utrecht	3430EM	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided