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Preventing Persistent Post-Surgical Pain and Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965897
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Barbara A Rakel, University of Iowa

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 BPI Pain Severity Subscale and level of functioning will be measured using the 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.


Condition or disease Intervention/treatment Phase
Pain Function Anxiety Depression Arthroplasty, Replacement, Knee Veterans Behavioral: Acceptance and Committment Therapy (ACT) Other: Attention Control (AC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Preventing Persistent Post-Surgical Pain and Dysfunction in At-Risk Veterans: Effect of a Brief Behavioral Intervention
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Attention Control (AC)
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)
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.

Experimental: Acceptance and Commitment Therapy (ACT)
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 Committment Therapy (ACT)
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.




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: Baseline (preop) to 6 months post-surgery. ]
    Pain will be measured using the Brief Pain Inventory (BPI) Short Form.

  2. Function [ Time Frame: Baseline (preop) to 6 months post-surgery ]
    Functioning will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS).


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: Baseline (preop) to 6 months post-surgery ]
    Anxiety will be measured using the Anxiety Subscale of the Depression, Anxiety and Stress Scale (DASS-21).

  2. Depressive Symptoms [ Time Frame: Baseline (preop) to 6 months post-surgery ]
    Depressive Symptoms will be measured using the Depression Subscale of the Depression, Anxiety and Stress Scale (DASS-21).

  3. Level of Pain Acceptance [ Time Frame: Baseline (preop) to 6 months post-surgery ]
    Pain Acceptance will be measured using the Chronic Pain Acceptance Questionnaire (CPAQ).

  4. Level of Success in Engagement in Values-Based Behavior [ Time Frame: Baseline (preop) to 6 months post-surgery ]
    Engagement in Values-Based Behavior will be measured using the Chronic Pain Values Inventory (CPVI).

  5. Pain Management Strategies used [ Time Frame: Baseline (preop) to 6 months post-surgery ]
    Pain Management Strategies will be measured using a Pain Management Strategies Survey (PMSS).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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].

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965897


Contacts
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Contact: Barbara Rakel, PhD 319-335-7036 barbara-rakel@uiowa.edu
Contact: Lilian Dindo, PhD 713-440-4637 lilian.dindo@bcm.edu

Locations
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United States, Iowa
Iowa City VAMC Recruiting
Iowa City, Iowa, United States, 52242
Contact: Barbara Rakel, PhD    319-335-7036    barbara-rakel@uiowa.edu   
Sponsors and Collaborators
Barbara A Rakel
Baylor College of Medicine
Investigators
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Principal Investigator: Barbara Rakel, PhD University of Iowa
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Responsible Party: Barbara A Rakel, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03965897    
Other Study ID Numbers: 201812794
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms