Treatment for Cubital Tunnel Syndrome | NCT00184158

Studies
Treatment for Cubital Tunnel Syndrome

NCT00184158

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 22, 2017Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Cubital Tunnel Syndrome

Interventions

decompression

Countries

Norway

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

Aug 2017

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

Jan 2005Actual

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

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

Aug 17, 2017

Last Update Posted Date

Aug 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments.

The study is performed at 5 different hospitals in Norway.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
decompression	Procedure	Conservative, simple decompression and nerve transfer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain

Secondary Outcomes

Measure	Description	Time Frame
electroneurography (ENG	electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
paresthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cubital tunnel syndrome

Exclusion Criteria:

Rheumatoid arthritis (RA)
Osteoarthrosis
Varus or valgus deformities at elbow

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vilhjalmur Finsen, Prof	National Taiwan Normal University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olavs Hospital		Trondheim		7006	Norway

Condition Browse Module

MeSH Terms

ID	Term
D020430	Cubital Tunnel Syndrome
D009463	Neuroma

Ancestor Terms

ID	Term
D020424	Ulnar Neuropathies
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003664	Decompression

Ancestor Terms

ID	Term
D013812	Therapeutics
D011312	Pressure
D055595	Mechanical Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided