N/A
Completed N=54
Pre-op Cognitive Behavior Therapy to Decrease Chronic Post-Surgical Pain in TKA
Source: ClinicalTrials.gov NCT04814992 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Preoperative Chronic Pain Severity — 4.6; 4.4 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.