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

Not Applicable

Completed

• Conditions: Catastrophization
• Interventions: Other: Cognitive Therapy; Other: Routine Care

• Registration Number: NCT01772329
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Primary Completion: 2020-08
• Study Completion: 2020-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-24
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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}.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 weekly CT sessions - Tele-video	Cognitive Therapy	4 weekly CT sessions; 1st and 4th will be 1-hr individual cognitive therapy session with the psychology staff. The intermediate CT sessions will be by telephone call or video/"Skype".
Routine care	Routine Care	Routine care; no CT sessions
4 weekly CT sessions - in person	Cognitive Therapy	4 weekly CT sessions; all will be 1-hr individual cognitive therapy sessions with the psychology staff (under the supervision of John Burns, PhD).
8 weekly CT sessions	Cognitive Therapy	8 weekly CT sessions; 1st and 8th will be 1-hr individual cognitive therapy session with the psychology staff (under the supervision of John Burns, PhD). The intermediate CT sessions will be by telephone call or video/"Skype". Our group will purchase and setup a web camera and headphone/microphone for the subjects in the CT groups that use "Skype". The 1-hr CT protocol was adapted from Dr. Beverly E. Thorn's CT manual (Cognitive Therapy for Chronic Pain: A Step-by-Step Guide; Thorn, 2004; with the Client and Therapy Workbooks.

Primary Outcome Measures

Name	Time	Method
(Aim 1) Pain Catastrophizing Scale (PCS)	4 or 8 weeks after start of treatment	Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.
(Aim 2) Proportion of patients with pain relief	3 month	Proportion of patients w a 3 month decrease in WOMAC pain subscale \<= 4. (WOMAC Osteoarthritis Index)

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-8)	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
Generalized anxiety disorder (GAD-7)	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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States