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fMRI Evaluation of Pain Central Sensitization Phenomena in Subjects With Knee Osteoarthritis

NCT01700634 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2016-10-05

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31
Completion
2016-10-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700634 on ClinicalTrials.gov