Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects

Catastrophization Clinical Trial

— CT_TKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772329
• Other study ID #: 12031901
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2020

Study information

• Verified date: June 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. undergoing standard primary TKR; THR or Shoulder Surgery

2. 18- 85 yrs of age;

3. Surgical joint is the primary source of patient's pain;

4. Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;

5. Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.

6. Patient has been diagnosed with osteoarthritis.

Exclusion Criteria:

1. Currently using antidepressant medication or undergoing cognitive therapy;

2. chronic opioid use = 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;

3. history of opioid abuse;

4. inability to understand and communicate with the investigators to complete the study related questionnaires

5. patient is planning to undergo another elective joint procedure during the 6-mo period of participation;

6. any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}.

Related Conditions & MeSH terms

• Catastrophization

Intervention

Other:
• Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
• Routine Care
Routine Care. No Cognitive Therapy Intervention

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Aim 1) Pain Catastrophizing Scale (PCS)	Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.	4 or 8 weeks after start of treatment
Primary	(Aim 2) Proportion of patients with pain relief	Proportion of patients w a 3 month decrease in WOMAC pain subscale <= 4. (WOMAC Osteoarthritis Index)	3 month
Secondary	Patient Health Questionnaire (PHQ-8)	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	4 and 8 weeks after start of treatment
Secondary	Generalized anxiety disorder (GAD-7)	Generalized anxiety disorder (GAD-7): The seven-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire.	4 and 8 weeks after start of treatment