Clinical trial NCT01772329: Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects
Official title: Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catastrophization
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-01-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2
Primary purpose: PREVENTION

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.

Eligibility 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}.

Primary outcomes:
measure: (Aim 1) Pain Catastrophizing Scale (PCS)
timeFrame: 4 or 8 weeks after start of treatment
measure: (Aim 2) Proportion of patients with pain relief
timeFrame: 3 month
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 4 and 8 weeks after start of treatment
measure: Generalized anxiety disorder (GAD-7)
timeFrame: 4 and 8 weeks after start of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush UMC
name: Asokumar Buvanendran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buvanendran A, Sremac AC, Merriman PA, Della Valle CJ, Burns JW, McCarthy RJ. Preoperative cognitive-behavioral therapy for reducing pain catastrophizing and improving pain outcomes after total knee replacement: a randomized clinical trial. Reg Anesth Pain Med. 2021 Apr;46(4):313-321. doi: 10.1136/rapm-2020-102258. Epub 2021 Jan 15.