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

Status Recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• ACL
• ACL Injury
• Anterior Cruciate Ligament Injuries

• NCT number: NCT05542563
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Contact: Kristin Haraldsdottir
• Phone: 608-263-6647
• Email: ACLMindfulnessResearch@ortho.wisc
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Completion date: April 2025