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Completed Not applicable Interventional Results available

Preventing Persistent Post-Surgical Pain and Dysfunction

ClinicalTrials.gov ID: NCT03965897

Public ClinicalTrials.gov record NCT03965897. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Preventing Persistent Post-Surgical Pain and Dysfunction in At-Risk Veterans: Effect of a Brief Behavioral Intervention

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary Aim: To examine the superior efficacy of ACT versus Attention Control (AC) on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA. Changes in pain intensity and functioning from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Level of pain intensity will be measured using the Brief Pain Inventory (BPI) Pain Severity Subscale and level of functioning will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living and Quality Of Life Subscales. Secondary Aims: A) To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills. Changes from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales (Ham-A and Ham-D, respectively). Coping skills (i.e. Pain Acceptance and Engagement in Values-Based Behavior) will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory. B) To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT. Changes in anxiety symptoms, depressive symptoms, pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months. Exploratory Aim: Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness. This will provide insights into the effects of the current opioid restrictions on pain management strategies. These strategies \& their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline, 6 weeks, 3, and 6 months.

Study identification

NCT ID
NCT03965897
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Iowa
Other
Enrollment
402 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 28, 2019
Primary completion
Jul 29, 2023
Completion
Jan 29, 2024
Last update posted
May 5, 2026

2019 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Iowa City VAMC Iowa City Iowa 52242

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03965897, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03965897 live on ClinicalTrials.gov.

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