Mindfulness and ACL Surgery

ACL Injury Clinical Trial

Official title:

The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542563
• Other study ID #: 2021-0845
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: Kristin Haraldsdottir
• Phone: 608-263-6647
• Email: ACLMindfulnessResearch[@]ortho.wisc
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes (PROs) following ACL reconstruction surgery.

Description:

Rationale and Approach: ACL reconstruction surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential adverse long-lasting effects such as muscle weakness, arthritis, persistent knee pain, anxiety, depression, post-traumatic stress, and fear of re-injury. Many of these patients report sufficient psychological trauma that undermines a return to sport and potentially contributes to the risk of re-injury to the repaired knee. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following ACL reconstruction surgery.

• Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes and return to sport following ACL reconstruction surgery

• Hypothesis 1: Mindfulness training will be associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery

• Specific Aim 2: To determine the influence of mindfulness training on re-injury risk following ACL reconstruction surgery

• Hypothesis 2: Among those participants that return to sport, mindfulness training will be associated with a decreased risk of ipsilateral ACL rupture in the 24 months following ACL reconstruction surgery

• Specific Aim 3: To determine the factors that influence mindfulness efficacy in patient-reported outcomes and return to sport following ACL reconstruction surgery

• Hypothesis 3: Among participants in the mindfulness group, total duration of mindfulness training and female gender will be independently associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

• 16-40 years old at the time of the pre-operative visit

• Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS)

• Undergoing ACL surgery

Exclusion Criteria:

• Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc).

• Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year

• Knee injury requiring multi-ligament reconstruction

• Prior ipsilateral knee surgery

• Prior contralateral ACL reconstruction

Related Conditions & MeSH terms

• ACL
• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Behavioral:
• Healthy Minds Program (HMP) App
The full HMP app includes 5 modules with practices designed to cultivate categories of mental and emotional skills linked to both hedonic and eudaimonic well-being. These include the cultivation of mindful attention (Awareness), positive relationships with self and others (Connection), insight into the nature of self and internal experience (Insight), and purpose, values, and meaning in life (Purpose), as well as an initial module which includes abbreviated introductions to the topics and lessons in all four areas (Foundations). For this study, the active intervention will include 4 weeks of training using the Foundations module followed by 4 weeks of training using the Awareness module.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PROMIS Global Health Questionnaire (GHQ) Score	Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in PROMIS Anxiety Questionnaire Score	Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in PROMIS Depression Questionnaire Score	Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in Single Assessment Numeric Evaluation (SANE) Score	Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in Horowitz Impact of Events Scale Score	Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score	Fear of re-injury is assessed via an 11-item survey scored from 1-4 where higher scores indicate a greater fear of re-injury.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in Pain Catastrophizing Scale (PCS) Score	Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score	Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in Athletic Identity Measurement Scale (AIMS) Score	Athletic identity is assessed via a 10-item survey with a total range of scores from 10-70 where higher scores indicate a higher level of athletic identity.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score	Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Primary	Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day	Higher score indicates higher physical activity.	baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Knee Range of Motion		6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Peak Torque	Participants will undergo testing of resisted flexion and extension to determine peak torque	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Peak Torque Relative to Body Weight	Participants will undergo testing of resisted flexion and extension to determine peak torque relative to body weight	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Hamstring to Quadriceps Torque Ratio	Participants will undergo testing of resisted flexion and extension to determine hamstring to quadriceps torque ratio.	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Change in Jump Landing Assessment: Force Measures	loading force, acceleration force, landing force, peak landing force on both legs together	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Change in Jump Height		6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Change in Vertical Hop Testing: Force Measures	down force, up force, landing force, peak landing force on a single leg	6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Change in Hop Height		6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Secondary	Total Duration of Mindfulness Intervention in the Mindfulness Group		up to 24 months
Secondary	Number of Participants Who Return to Sport		up to 24 months