Osteoarthritis Clinical Trial
Official title:
fMRI Evaluation of Pain Central Sensitization Phenomena in Subjects With Knee Osteoarthritis
The aim of this project is to investigate fMRI ability to identify pain central
sensitization in chronic knee OA. Patients with high and low central sensitization and
healthy control subjects will be included. Central sensitization will be clinically defined
based on the evidence of regional spread of pain (spreading sensitization) and increased
pain response to repeated stimulation (temporal summation). Operatively, a patient will be
assigned to high sensitization group when showing (i) clinical evidence of pain or altered
sensations spread beyond the knee joint by manual palpation, (ii) a minimum of 3 anatomical
sites around the knee showing a pressure pain threshold below 4 kg/cm2 (tender points),
(iii) pain score of 4 points or more in a 11-point scale during 4 kg/cm2 pressure
stimulation on the anterior/medial surface of the tibial bone (the site selected for the
fMRI experiment) and (iv) increase of at least 1 point in a 11-point scale after 10 repeated
pressure stimulation on the tenderest point around the knee.
A three-step strategy is proposed to characterize the phenomenon by assessing (i) brain
response to direct pressure stimulation on the painful knee, which will reflect the
combination of peripheral and central sensitization; (ii) brain response to pressure
stimulation on a non-arthritic hyperalgesic area (i.e., the anterior surface of the tibia),
which will mostly reflect central sensitization mediated at the spinal cord level, and (iii)
brain response to moderately painful heat stimulation on a healthy skin area (i.e., volar
forearm), which will reflect central sensitization occurring in the brain and involving the
highest-level pain modulatory mechanisms. An additional evaluation is proposed using
resting-state fMRI to assess potential alterations in baseline brain functional
organization.
n/a
Observational Model: Case-Crossover, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
| Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
| Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
| Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
| Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
| Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
| Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
| Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
| Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
| Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
| Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
| Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
| Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
| Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
| Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
| Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
| Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A | |
| Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A |