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

NCT01772329

Last updated date
Study Location
Rush University Medical Center
Chicago, Illinois, 60612, United States
Contact
312-942-2806

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Catastrophization
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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}.

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CatastrophizationPreoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects
NCT01772329
  1. Chicago, Illinois
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects
Official Title  ICMJE Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Catastrophization
Intervention  ICMJE
  • Other: Cognitive Therapy
    CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
  • Other: Routine Care
    Routine Care. No Cognitive Therapy Intervention
Study Arms  ICMJE
  • 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).
    Intervention: Other: Cognitive Therapy
  • 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.
    Intervention: Other: Cognitive Therapy
  • 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".
    Intervention: Other: Cognitive Therapy
  • Placebo Comparator: Routine care
    Routine care; no CT sessions
    Intervention: Other: Routine Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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}.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mario Moric312-942-2806[email protected]
Contact: Sherry J Robison, MBA(312) 942-2985[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01772329
Other Study ID Numbers  ICMJE 12031901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Plan Description:No plan to share data as of yet but may be willing to.
Responsible Party Asokumar Buvanendran, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Asokumar Buvanendran, MDRush UMC
PRS Account Rush University Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP