N/A N=54 Randomized Treatment

Pre-op Cognitive Behavior Therapy to Decrease Chronic Post-Surgical Pain in TKA

Chronic Post-Surgical Pain

Bottom Line

View on ClinicalTrials.gov: NCT04814992 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Preoperative Chronic Pain Severity — 4.6; 4.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Computer-Assisted Preoperative CBT Intervention (PAINTrainer) (Behavioral)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Preoperative Chronic Pain Severity	4.6; 4.4	—
SECONDARY Preoperative Opioid Use	15.8; 11.4	—
SECONDARY Post-operative Opioid Use	11.4; 12.0	—
SECONDARY Pre-Op Depression	10.6; 11.2	—
SECONDARY Post-Op Depression	8.5; 10.6	—
SECONDARY Pre-Op Anxiety	13.0; 12.4	—
SECONDARY Post-Op Anxiety	9.1; 10.8	—
SECONDARY Pre-Op Catastrophizing	10.8; 12.2	—
SECONDARY Post-Op Pain Severity	4.6; 4.8	—
SECONDARY Chronic Post-Surgical Pain	6; 4	—
SECONDARY Post-operative Chronic Pain Intensity	3.1; 3.7	—

Summary

A significant number of patients develop chronic post-surgical pain (CPSP) following knee replacement surgery. Proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for CPSP, with the expectation that severity of post-op pain and the incidence of CPSP will be reduced.

Eligibility Criteria

Inclusion Criteria

Males and females, age > 21 years
Chronic non-malignant pain of at least 3 months duration
Morphine equivalent daily dose (MEDD) > 40 milligrams for at least 3 months
Able to enroll at least 4 weeks prior to planned surgery
Able to speak, read and comprehend in English at the 6th grade or higher proficiency

Exclusion Criteria

Pain of malignant origin
Current or past history of opioid use disorder (including those on medication-assisted therapy)
Revision of TKA
Comorbid CNS disease such as dementia, HIV, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04814992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.