Effects of an online program including mindfulness, exercise therapy and patient education compared to online exercise therapy and patient education for people with Patellofemoral Pain: protocol for a randomized clinical trial.
Liliam Barbuglio Del Priore, Vitoria Ozores Perez, Ronaldo Valdir Briani, Lucca Andre Liporoni Bego Farinelli, Júlia de Cássia Pinto Da Silva, Odisséia Marli Gimenes Martins, Fábio Arruda Lopes, Anita Barros Amorim, Evangelos Pappas, Fábio Mícolis De Azevedo
BMC musculoskeletal disorders May 11, 2023 DOI: 10.1186/s12891-023-06491-x (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized clinical trial Peer reviewed |
|---|---|
| Sample size | 62 |
| Population | People with patellofemoral pain |
| Interventions | Exercise therapy patient education mindfulness-based intervention |
| Duration | 8-week intervention, 12-month follow-up |
| Topics | Meditation |
| Keywords | Anterior knee pain Education Exercise therapy Psychological factors |
| Citations | 7 |
| Key findings | The study protocol describes a planned trial to test whether adding an online mindfulness-based intervention to exercise therapy and education improves clinical and psychological outcomes for people with patellofemoral pain. |
Abstract
Patellofemoral pain (PFP) is a common knee disorder that causes persistent pain, lower self-reported function and quality of life. People with PFP also present with altered psychological factors, which are associated with higher levels of pain and dysfunction. Mindfulness-based interventions (MBI) generally consist of meditative practices developed to provide a holistic approach to chronic conditions. However, the effects of MBI on clinical and psychological outcomes for people with PFP remains understudied. This assessor-blinded, parallel, two-arm randomized clinical trial aims to investigate the effects of adding an 8-week online MBI program to exercise therapy and patient education on clinical and psychological factors for people with PFP. We also aim to investigate whether psychological factors mediate changes in pain and function. Sixty-two participants with PFP will be recruited and randomized into one of two treatment groups (Mindfulness or Control group). Both groups will receive an 8-week intervention involving exercise therapy and education delivered through an online platform. The Mindfulness group will additionally receive a MBI component including formal and informal practices. Outcomes will be assessed online at baseline, intervention endpoint (follow-up 1) and 12 months after intervention completion (follow-up 2). Comparisons between groups will be performed at all time points with linear mixed models. A mediation analysis will be performed using a 3-variable framework. Exercise therapy and patient education are considered the "best management" options for PFP. However, unsatisfactory long-term prognosis remains an issue. It is known that people with PFP present with altered psychological factors, which should be considered during the evaluation and treatment of people with PFP. Adding a MBI to the current best treatment for PFP may improve short and long-term effects by addressing the underlying psychological factors. Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-4yhbqwk, registered in April 6, 2021.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 13
- Mindfulness: A proposed operational definition. Clinical Psychology Science and Practice 2004
- What defines mindfulness-based programs? The warp and the weft Psychological Medicine December 29, 2016
- The Meditative Mind: A Comprehensive Meta-Analysis of MRI Studies BioMed Research International 2015
- Evaluation of the breathworks mindfulness‐based pain management programme: effects on well‐being and multiple measures of mindfulness Clinical Psychology & Psychotherapy November 13, 2009
- The impact of a brief mindfulness training on interoception: A randomized controlled trial PLoS One September 7, 2022
and 8 more in the library