Preventing Persistent Post-Surgical Pain and Dysfunction

Completed · Not applicable

Conditions studied: Pain, Function, Anxiety, Depression, Arthroplasty, Replacement, Knee, Veterans

In brief

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.

Key facts

Study ID

NCT03965897

Run by

University of Iowa

People needed

402

Starts

2019-07-29

Expected to finish

2024-01-30

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• scheduled for unilateral total knee arthroplasty (TKA)
• identified to be "at-risk" at the enrollment visit (i.e. worst pain ≥7 on BPI (severe pain) OR worst pain ≥3 (moderate pain) on BPI PLUS anxiety symptoms ≥6 on the Anxiety Subscale of the Depression, Anxiety and Stress Scale [DASS-21] or ≥10 on the Stress Subscale of the Depression, Anxiety and Stress Scale [DASS-21] OR depressive symptoms ≥7 on Depression Subscale of the Depression, Anxiety and Stress Scale [DASS-21] OR >20 on the Pain Catastrophizing Scale [PCS].

You may not qualify if…

• inability to complete study forms/procedures because of a language/literacy barrier;
• bipolar or psychotic disorder
• history of brain injury
• cognitive impairment (determined by score of <21 [high school or above] or <20 [< high school] on the Veterans Affairs Saint Louis University Mental Status [SLUMS] exam)
• ACT therapy within the past year
• inability to attend workshop prior to surgery

Where it is running

• Iowa City VAMC — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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