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

NCT01772329 | Completed

• 1 other identifier: 12031901
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Catastrophization

Outcome Measures

Primary Outcomes (2)

• (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

Secondary Outcomes (2)

• Patient Health Questionnaire (PHQ-8)

  4 and 8 weeks after start of treatment

• Generalized anxiety disorder (GAD-7)

  4 and 8 weeks after start of treatment

Study Arms (4)

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).

Other: Cognitive Therapy

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.

Other: Cognitive Therapy

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".

Other: Cognitive Therapy

Routine care

PLACEBO COMPARATOR

Routine care; no CT sessions

Other: Routine Care

Interventions

Cognitive Therapy OTHER

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

4 weekly CT sessions - Tele-video; 4 weekly CT sessions - in person; 8 weekly CT sessions

Routine Care OTHER

Routine Care. No Cognitive Therapy Intervention

Routine care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing standard primary TKR; THR or Shoulder Surgery
• 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.

You may not qualify if:

• 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}.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 33452201 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Asokumar Buvanendran, MD

  Rush UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Anesthesiology

Model Details: n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)