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Completed

NCT Number: NCT01772329

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing standard primary TKR; THR or Shoulder Surgery
  • 18- 85 yrs of age;
  • Surgical joint is the primary source of patient's pain;
  • Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
  • Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
  • Patient has been diagnosed with osteoarthritis.

Exclusion criteria

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

Treatment and study plan

Cognitive therapy

Other

CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

Routine care

Other

Routine Care. No Cognitive Therapy Intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: CT_TKA

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2013
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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