NCT00379184

Brief Summary

Musculoskeletal pains represent a major part of pain complaints in patients. Moreover, the treatment of musculoskeletal pain conditions by currently available drugs is not optimal (Curatolo and Bogduk 2001). Thus, deep pain is a diagnostic and therapeutic problem, and further insights into the peripheral and central neurophysiologic mechanisms are necessary to improve diagnosis and therapy and to implement a mechanism-based approach. Peripheral sensitization and central hyper excitability are, most likely the important factors for chronic musculoskeletal pain and in particular osteoarthritis (OA). The focus of this project is to study the involvement of peripheral and central sensitization underlying deep tissue hyperalgesia and referred pain in male and female OA patients. Adequate quantitative sensory testing assessment techniques for measuring hyper excitability are needed to investigate, in more detail the mechanisms involved in generating the sensitization in OA patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

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

September 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

September 19, 2006

Last Update Submit

March 28, 2014

Conditions

Arthritis

Keywords

arthritis

Study Arms (3)

A

Osteoarthritis patients scheduled for Total Knee Arthroplasty.

B

Osteoarthritis patients not scheduled for Total Knee Arthroplasty.

C

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with knee OA

You may qualify if:

  • Osteoarthritis in the knee

You may not qualify if:

  • No other painful conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital and Aalborg University

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Mogens B Laursen, MD, PhD

    Northern Orthopaedic Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

DK(1)