Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects
NCT01772329
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
312-942-2806
Adult Trials: 18+ Years
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.
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}.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Chicago, Illinois
| 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 |
| ||||||||
| Study Arms ICMJE |
| ||||||||
| 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 | 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:
Exclusion Criteria:
| ||||||||
| Sex/Gender ICMJE |
| ||||||||
| Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
| ||||||||
| 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 |
| ||||||||
| Responsible Party | Asokumar Buvanendran, Rush University Medical Center | ||||||||
| Study Sponsor ICMJE | Rush University Medical Center | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
| ||||||||
| 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 | |||||||||