Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 weekly CT sessions - in person | Experimental | 4 weekly CT sessions; all will be 1-hr individual cognitive therapy sessions with the psychology staff (under the supervision of John Burns, PhD). |
|
| 8 weekly CT sessions | Experimental | 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. |
|
| 4 weekly CT sessions - Tele-video | Experimental | 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". |
|
| Routine care | Placebo Comparator | Routine care; no CT sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Therapy | Other | CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Aim 1) Pain Catastrophizing Scale (PCS) | Pain Catastrophizing Scale - Min=0, Max=52, Higher score = more catastrophizing so lower scores are preferable. | 4 or 8 weeks after start of treatment |
| (Aim 2) Proportion of patients with pain relief | Proportion of patients w a 3 month decrease in WOMAC pain subscale <= 4. (WOMAC Osteoarthritis Index) | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | 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 | 4 and 8 weeks after start of treatment |
| Generalized anxiety disorder (GAD-7) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Asokumar Buvanendran, MD | Rush UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33452201 | Derived | 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. |
Not provided
Not provided
No plan to share data as of yet but may be willing to.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2
Not provided
Not provided
Not provided
| Routine Care | Other | Routine Care. No Cognitive Therapy Intervention |
|
Generalized anxiety disorder (GAD-7): The seven-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire. |
| 4 and 8 weeks after start of treatment |