Preventing Persistent Post-Surgical Pain and Dysfunction

NCT03965897 | Completed Results DMC

• 2 other identifiers: 2018127941R01NR017610-01A1
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Function; Anxiety; Depression; Veterans; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  Pain will be measured using the Brief Pain Inventory (BPI) Scale: 0-10, with higher scores meaning worse pain

  6 weeks postop, 3 months postop and 6 months postop

• Function

  Knee Injury and Osteoarthritis Outcome Score (KOOS), Activities of Daily Living (ADL) subscore. Scale: 0-100, with lower scores indicating poorer function.

  6 weeks postop, 3 months postop, and 6 months postop

Secondary Outcomes (5)

• Anxiety

  6 weeks postop, 3 months postop, and 6 months postop

• Depressive Symptoms

  6 weeks postop, 3 months postop, and 6 months postop

• Level of Pain Acceptance

  6 weeks postop, 3 months postop, and 6 months postop

• Level of Success in Engagement in Values-Based Behavior

  6 weeks postop, 3 months postop, and 6 months postop

• Number of Participants Using Pain Management Strategies

  3 months postop and 6 months postop

Study Arms (2)

Attention Control (AC)

ACTIVE COMPARATOR

The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.

Other: Attention Control (AC)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

Overall, the goal of the ACT intervention is to cultivate psychological flexibility: to help Veterans respond to life events in ways which do not exacerbate difficulties or restrict engagement in meaningful activities. It increases patients' awareness of behaviors that exacerbate the pain (such as struggling with it) and recognition of avoidance strategies that interfere with life engagement.

Acceptance and Commitment Therapy (ACT)

Attention Control (AC) OTHER

Information on any other coping practices will be omitted. The group facilitators will present one topic at a time, using the Pain Manual, and the participants will discuss and reflect about issues and experiences related to each topic. If necessary, the group facilitators will raise specific discussion questions to facilitate group dialogue and participant involvement.

Attention Control (AC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Iowa: lead
• Baylor College of Medicine: collaborator
• National Institute of Nursing Research (NINR): collaborator
• Iowa City Veterans Affairs Medical Center: collaborator

Study Sites (1)

Iowa City VAMC

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Shanahan ML, Zimmerman B, Rodrigues M, Green D, Embree J, Buckwalter J, Garvin L, Hadlandsmyth K, Smith T, Rakel B, Dindo L. Intersectional pain disparities and resilience in veterans with chronic pain. Health Psychol. 2026 Jan;45(1):123-135. doi: 10.1037/hea0001555.

  PMID: 41396638 DERIVED

• Dindo L, Hadlandsmyth K, Garvin L, Marchman J, Zimmerman MB, Buckwalter JA 4th, Green DM, Wollaeger JK, Strayer A, Kim KS, Liu W, Embree J, Rodrigues M, Rakel BA. ACT for postsurgical pain and dysfunction in at-risk veterans: Multisite, double-blind, cluster RCT. J Psychosom Res. 2025 Nov;198:112393. doi: 10.1016/j.jpsychores.2025.112393. Epub 2025 Sep 24.

  PMID: 41032959 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

There were three limitations of this study: 1. A treatment as usual group was not included to know whether the two active treatments resulted in significantly better outcomes than no added treatment. 2. Due to the COVID pandemic, group workshops had to be revised from in-person to virtual which may have influenced the results. 3. The sample was primarily male. While this is representative of the veteran population, these results are not generalizable to female veterans.

Results Point of Contact

• Title: Barbara Rakel, Professor Emeritus
• Organization: University of Iowa

barbara-rakel@uiowa.edu

(319) 331-2978

Study Officials

• Barbara Rakel, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants and outcome assessors are blinded to treatment. Allocation to intervention group remains concealed until the beginning of the workshop when all invited participants have arrived. Those in attendance will receive the assigned intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a cluster randomization approach where the unit of randomization is the workshops. Randomization occurs at the start of each workshop so that all participants attending that workshop are randomized to that intervention (i.e. ACT vs. AC). Statistician Dr. Zimmerman generates the randomization sequence using PLAN procedure (SAS v9.2). Randomization of workshops occurs in permuted blocks of 2 and 4 and are stratified by site (i.e. Iowa City versus Houston).

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: July 29, 2019
• Primary Completion: July 30, 2023
• Study Completion: January 30, 2024
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)