Back to resultsNSAID Treatment of Patients With Osteoarthritis
Primary Purpose
Osteoarthritis,Knee
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
NSAID
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoarthritis,Knee
Eligibility Criteria
Inclusion Criteria:
- Diagnosed Knee Ostoarthritis
Exclusion Criteria:
- Current ulcer diagnosed by endoscope
- Asthma or other allergic reaction to NSIADs
- Kidney disease
- Myocardial infarction within the last six months
- Severe hyper tension (systolic ≥180mmHg, diastolic ≥110mmHg)
- Severe thrombocytopenia (thrombocyst count <50x10^9/l)
- Insufficience lever or kidney function
Sites / Locations
- Center for Sensory Motor Interaction, Aalborg University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NSAID treatment
Arm Description
8 weeks of NSAID treatment
Outcomes
Primary Outcome Measures
Pain intensity measured on a 10cm visual analog scale
Patients will be asked to rate the pain intensity 8 weeks after treatment on a 10cm visual analog scale (0 indicating no pain, 10 indicating worst imaginable pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02967744
Brief Title
NSAID Treatment of Patients With Osteoarthritis
Official Title
BEVAR: Patientspecifik Behandling Ved Artrose - Et "Proof-of-concept"- Kvalitetssikringsstudie
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates associations between pre treatment pain intensity and central pain mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis,Knee
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSAID treatment
Arm Type
Experimental
Arm Description
8 weeks of NSAID treatment
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
NSAIDs are among the most common pain treatments for patients with osteoarthritis.
Primary Outcome Measure Information:
Title
Pain intensity measured on a 10cm visual analog scale
Description
Patients will be asked to rate the pain intensity 8 weeks after treatment on a 10cm visual analog scale (0 indicating no pain, 10 indicating worst imaginable pain
Time Frame
8 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed Knee Ostoarthritis
Exclusion Criteria:
Current ulcer diagnosed by endoscope
Asthma or other allergic reaction to NSIADs
Kidney disease
Myocardial infarction within the last six months
Severe hyper tension (systolic ≥180mmHg, diastolic ≥110mmHg)
Severe thrombocytopenia (thrombocyst count <50x10^9/l)
Insufficience lever or kidney function
Facility Information:
Facility Name
Center for Sensory Motor Interaction, Aalborg University
City
Aalborg East
ZIP/Postal Code
9220
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
NSAID Treatment of Patients With Osteoarthritis
We'll reach out to this number within 24 hrs