N/A Completed N=21 Single-blind Basic Science

Brain Morphometry in OA Patients Treated With Duloxetine

Postoperative Pain · Osteoarthritis

Source: ClinicalTrials.gov NCT02903238 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: Brain Regional Gray Matter Density — 0.420; 0.425 Gray Matter Density: 0 to 1

Summary

This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.

Outcome Measures

Outcome	Result	p-value
PRIMARY Brain Regional Gray Matter Density	0.420; 0.425	—
SECONDARY WOMAC Pain Index	38.6; 4.6	—
SECONDARY Overall Brain Neocortical Gray Matter Volume	—	—

Eligibility Criteria

Inclusion Criteria

Age: 40-85 years
ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
Knee OA for a minimum of 12 months
Need for daily pain medication to manage symptoms of OA

Exclusion Criteria

Currently taking MAO inhibitors or any centrally acting drug for analgesia
Narrow angle glaucoma
Uncontrolled hypertension
Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
If a female, pregnant, trying to become pregnant, or lactating
Major depressive disorder
Substantial alcohol use or history of significant liver disease
Diabetes, type 1 or type 2
Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
Standard MRI safety exclusions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02903238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.