Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects

Rush University Medical Center1 site in 1 country160 target enrollmentJanuary 2013

ConditionsCatastrophization

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Catastrophization
Sponsor: Rush University Medical Center
Enrollment: 160
Locations: 1
Primary Endpoint: (Aim 1) Pain Catastrophizing Scale (PCS)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

October 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rush University Medical Center

Responsible Party

Principal Investigator

Asokumar Buvanendran

Profesor Anesthesiology

Rush University Medical Center

Eligibility Criteria

Inclusion Criteria

•undergoing standard primary TKR; THR or Shoulder Surgery
•18- 85 yrs of age;
•Surgical joint is the primary source of patient's pain;
•Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
•Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
•Patient has been diagnosed with osteoarthritis.

Exclusion Criteria

•Currently using antidepressant medication or undergoing cognitive therapy;
•chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use \> 4 wks;
•history of opioid abuse;
•inability to understand and communicate with the investigators to complete the study related questionnaires
•patient is planning to undergo another elective joint procedure during the 6-mo period of participation;
•any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification \> 3}.