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

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ClinicalTrials.gov Identifier: NCT01772329
Recruitment Status : Recruiting
First Posted : January 21, 2013
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Asokumar Buvanendran, 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.

Condition or disease Intervention/treatment Phase
Catastrophization Other: Cognitive Therapy Other: Routine Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects
Study Start Date : January 2013
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: 4 weekly CT sessions - in person
4 weekly CT sessions; all will be 1-hr individual cognitive therapy sessions with the psychology staff (under the supervision of John Burns, PhD).
Other: Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

Experimental: 8 weekly CT sessions
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.
Other: Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

Experimental: 4 weekly CT sessions - Tele-video
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".
Other: Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

Placebo Comparator: Routine care
Routine care; no CT sessions
Other: Routine Care
Routine Care. No Cognitive Therapy Intervention




Primary Outcome Measures :
  1. (Aim 1) Pain Catastrophizing Scale (PCS) [ Time Frame: 4 or 8 weeks after start of treatment ]
    Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable.

  2. (Aim 2) Proportion of patients with pain relief [ Time Frame: 3 month ]
    Proportion of patients w a 3 month decrease in WOMAC pain subscale <= 4. (WOMAC Osteoarthritis Index)


Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-8) [ Time Frame: 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

  2. Generalized anxiety disorder (GAD-7) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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}.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772329


Contacts
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Contact: Mario Moric 312-942-2806 mario_moric@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mario Moric    312-942-2806    mario_moric@rush.edu   
Principal Investigator: Asokumar Buvanendran, MD         
Sponsors and Collaborators
Rush University Medical Center
Pfizer
Investigators
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Principal Investigator: Asokumar Buvanendran, MD Rush UMC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asokumar Buvanendran, Profesor Anesthesiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01772329    
Other Study ID Numbers: 12031901
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data as of yet but may be willing to.