NCT02967744

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration 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, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

November 14, 2016

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks after treatment

Study Arms (1)

NSAID treatment

EXPERIMENTAL

8 weeks of NSAID treatment

Drug: NSAID

Interventions

NSAIDDRUG

NSAIDs are among the most common pain treatments for patients with osteoarthritis.

NSAID treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed Knee Ostoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Sensory Motor Interaction, Aalborg University

Aalborg East, 9220, Denmark

Location

Related Publications (2)

  • Giordano R, Arendt-Nielsen L, Hertel E, Olesen AE, Petersen KK. Multifactorial Machine Learning Algorithm Integration of Pain Mechanisms Can Predict the Efficacy of 3-Week NSAID Plus Paracetamol in Patients With Painful Knee Osteoarthritis. Eur J Pain. 2025 Nov;29(10):e70140. doi: 10.1002/ejp.70140.

  • Hertel E, Arendt-Nielsen L, Olesen AE, Andersen MS, Petersen KK. Quantitative sensory testing, psychological factors, and quality of life as predictors of current and future pain in patients with knee osteoarthritis. Pain. 2024 Aug 1;165(8):1719-1726. doi: 10.1097/j.pain.0000000000003194. Epub 2024 Feb 20.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 18, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations