Nerve Entrapment in Diabetic Patients | NCT00775333

Studies
Nerve Entrapment in Diabetic Patients

NCT00775333

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Oct 20, 2008Estimated

Enrollment

67Actual

Phase

Not provided

Conditions

Carpal Tunnel Syndrome
Entrapment Neuropathies
Nerve Compression Syndromes
Diabetes Complications

Interventions

Outcome after carpal tunnel release

Countries

Sweden

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

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Oct 17, 2008

First Submission Date that Met QC Criteria

Oct 17, 2008

First Posted Date

Oct 20, 2008Estimated

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

Oct 17, 2008

Last Update Posted Date

Oct 20, 2008Estimated

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 aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.

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

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with diabetes and carpal tunnel syndrome
2		Non-diabetic patients with carpal tunnel syndrome	Procedure: Outcome after carpal tunnel release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Outcome after carpal tunnel release	Procedure	Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength)		Baseline, 6 weeks, 12 weeks, 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pillar pain, cold intolerance, and patient satisfaction.		Baseline, 6 weeks, 12 weeks, 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome
Confirmed by nerve conduction studies.

Exclusion Criteria:

Other focal nerve entrapments
Cervical radiculopathy
Inflammatory joint disease
Renal failure
Thyroid disorders
Previous wrist fracture
Long-term exposure to vibrating tools.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients referred to a specialized hand clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Dahlin, PHD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Hand Surgery, Malmo University Hospital		Malmö		205 02	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome
D009408	Nerve Compression Syndromes
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D017060	Patient Satisfaction

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