Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 80
Inclusion Criteria
- 18- 85 yrs of age;
- Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
- Surgical joint is the primary source of patient's pain;
- ...
- 18- 85 yrs of age;
- Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
- Surgical joint is the primary source of patient's pain;
- Patient has been diagnosed with osteoarthritis.
- undergoing standard primary TKR; THR or Shoulder Surgery
- Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
Exclusion Criteria
- 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;
- Currently using antidepressant medication or undergoing cognitive therapy;
- ...
- 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;
- 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;
- any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}.
Summary
- Conditions
- Catastrophization
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Intervention Model Description: n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2Masking: Single (Investigator)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
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 t...
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.
Inclusion Criteria
- 18- 85 yrs of age;
- Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
- Surgical joint is the primary source of patient's pain;
- ...
- 18- 85 yrs of age;
- Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
- Surgical joint is the primary source of patient's pain;
- Patient has been diagnosed with osteoarthritis.
- undergoing standard primary TKR; THR or Shoulder Surgery
- Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
Exclusion Criteria
- 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;
- Currently using antidepressant medication or undergoing cognitive therapy;
- ...
- 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;
- 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;
- any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}.
Tracking Information
- NCT #
- NCT01772329
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: Asokumar Buvanendran, MD Rush UMC
- Asokumar Buvanendran, MD Rush UMC