CompletedNot Applicable

Preventing Persistent Post-Surgical Pain and Dysfunction

United States402 participantsStarted 2019-07-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity

Timeframe: 6 weeks postop, 3 months postop and 6 months postop

Function

Timeframe: 6 weeks postop, 3 months postop, and 6 months postop

Trial details

NCT IDNCT03965897

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-30

Results submitted2025-04-08

View on ClinicalTrials.gov More Pain trials