Rush University Medical Center
Chicago, Illinois, 60612, United States
NCT Number: NCT01772329
The investigators propose a randomized controlled trial to evaluate the effects of treatment intended to reduce pain catastrophizing among patients reporting high pain catastrophizing prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor of PPP following total knee replacement is highly innovative and have potentially high impact for public health. Cognitive therapy is a well-tolerated modality among chronic pain patients with few if any side effects. Cognitive therapy (CT) represents an inexpensive method that could greatly reduce suffering and costly post-surgical pain management for high risk TKR patients.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Aim 1 is to determine which CT protocol is most effective in reducing Pain Catastrophizing Scale (PCS) and Coping Strategies Questionnaire Catastrophizing Subscale (CSQ-CAT) scores in high-risk TKR candidates. CT will consist of four-to-eight weekly 1-hr individual cognitive therapy sessions prior to surgery.
Aim 2 is to compare the most efficient treatment from Aim 1 with a control group to evaluate pain relief at 3 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
Routine Care. No Cognitive Therapy Intervention
Time frame: 4 or 8 weeks after start of treatment
Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.
Time frame: 3 month
Proportion of patients w a 3 month decrease in WOMAC pain subscale <= 4. (WOMAC Osteoarthritis Index)
Time frame: 4 and 8 weeks after start of treatment
Patient Health Questionnaire (PHQ-8): The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders
Time frame: 4 and 8 weeks after start of treatment
Generalized anxiety disorder (GAD-7): The seven-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire.
Rush University Medical Center
Other
Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects
Acronym: CT_TKA
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