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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
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 |
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