Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2011-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Acupuncture Functional Magnetic Resonance Imaging (fMRI) Study on Chronic Pain: Response Reliability and Dose Effect

NCT01079390

Osteoarthritis, Knee

COMPLETED NA

An fMRI Study of Opioid-related Changes in Neural Activity

NCT02818036

Social Acceptance

COMPLETED NA

Brain Activation During Accommodation to Painful Stimulation With FMRI

NCT01242540

Pain

COMPLETED

Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

NCT01970943

Migraine Healthy

COMPLETED NA

The Functional Magnetic Resonance Imaging Study on the Processing of Acute Pain and Cognition Among Perimenopause Women

NCT02820974

Menopause Migraine

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. In this study, BOLD response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee OA following four treatment doses of any of three treatment will be compared.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Paracetamol caplets

Two 665 mg sustained release paracetamol caplets administered orally with water.

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

665 mg sustained release paracetamol caplets

Placebo caplets

Two placebo caplets administered orally with water.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo caplets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paracetamol

665 mg sustained release paracetamol caplets

Intervention Type DRUG

Placebo

Placebo caplets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of osteoarthritis of at least one knee for 3 months
* Male or female at least 45 years of age
* Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at screening

Exclusion Criteria

* If female, is pregnant, lactating, or breast feeding
* Has secondary cause of knee arthritis
* Lower extremity surgery in the last 6 months
* Prior injury in the last twelve months to the index knee
* Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start
* Recently used oral or injected glucocorticoids

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No