NCT00184158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

September 12, 2005

Last Update Submit

August 17, 2017

Conditions

Cubital Tunnel Syndrome

Keywords

Cubital tunneltreatmentnerve compression

Outcome Measures

Primary Outcomes (1)

  • pain

Secondary Outcomes (4)

  • electroneurography (ENG

  • paresthesia

  • weakness

  • patient satisfaction

Interventions

decompressionPROCEDURE

Conservative, simple decompression and nerve transfer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cubital tunnel syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Cubital Tunnel SyndromeNeuroma

Interventions

Decompression

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Officials

  • Vilhjalmur Finsen, Prof

    National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

NO(1)