Recruitment

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