SPAC-2
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StatusAccepting Candidates
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Age45 Years - 85 Years
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SexesAll
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Healthy VolunteersNo
Objective
This study experimentally manipulates pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain in different ethnic groups among adults with knee osteoarthritis. Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.
Details
Full study title | Neural mechanisms underlying psychosocial contribution to ethnic group differences in pain. [Study of Pain Catastrophizing-2] (SPAC-2) |
Protocol number | OCR40995 |
ClinicalTrials.gov ID | NCT04805190 |
Phase | N/A |
Eligibility
Inclusion Criteria:
- Symptomatic knee OA
Exclusion Criteria:
Younger than 45 years of age or older than 85 years of age
Prosthetic knee replacement or other clinically significant surgery to the arthritic knee
Uncontrolled hypertension (>150/95)
Heart disease including heart failure
Peripheral neuropathy in which pain testing was contraindicated
Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia
Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures
Significantly greater pain in body sites other than in the knee
Daily opioid use
Hospitalization within the preceding year for psychiatric illness
Currently pregnant or nursing/breastfeeding
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Ellen Terry -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.