Dataset Information

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.

ABSTRACT:

Background

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.

Methods

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.

Discussion

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.

Trial registration

Registro Brasileiro de Ensaios Clínicos (ReBEC) RBR-4yhbqwk, registered in April 6, 2021.

SUBMITTER: Priore LBD

PROVIDER: S-EPMC10173555 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

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.

Priore Liliam Barbuglio Del LBD Perez Vitoria Ozores VO Briani Ronaldo Valdir RV Farinelli Lucca Andre Liporoni Bego LALB da Silva Júlia de Cássia Pinto JCP Martins Odisséia Marli Gimenes OMG Lopes Fábio Arruda FA Amorim Anita Barros AB Pappas Evangelos E de Azevedo Fábio Mícolis FM

BMC musculoskeletal disorders 20230511 1

<h4>Background</h4>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 peopl ...[more]

PMID: 37170262

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Project description:ContextConsidering current models that highlight the role of psychological components in pain management, mindfulness practice may be an effective strategy in the management of pain.ObjectiveTo examine the effects of adding an 8-week mindfulness program to exercise therapy on the perceptions of pain severity, knee function, fear of movement, and pain catastrophizing of female recreational runners with patellofemoral pain (PFP).DesignRandomized controlled clinical trial.SettingUniversity laboratory.Patients or other participantsThirty female runners (age = 28.3 ± 7.08 years) with PFP were randomly assigned to the exercise or mindfulness-exercise group.Intervention(s)The exercise-only group followed a protocol (18 weeks, 3 sessions/wk) that featured training modifications to help control injury-related symptoms. The mindfulness-exercise group received an 8-week mindfulness intervention in addition to the exercise protocol. The mindfulness component started 4 weeks before the exercise component; therefore, the 2 components overlapped during the first 4 weeks of the intervention.Main outcome measure(s)Usual pain, pain during stepping, and pain during running were assessed using visual analog scales. Functional limitations of the knee were assessed using the Knee Outcome Survey. Fear of movement, pain catastrophizing, and coping strategies were measured via the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, and the Coping Strategies Questionnaire, respectively. These outcomes were assessed at baseline, at week 9, and after 18 weeks.ResultsPain during running, pain during stepping, and functional limitations of the knee were less for the mindfulness-exercise group than for the exercise-only group (P values < .05). The mindfulness-exercise group reported greater perceived treatment effects than the exercise-only group (P < .05). Pain catastrophizing was less and coping strategies were more favorable for mindfulness-exercise participants than for exercise-only participants (P values < .05).ConclusionsMindfulness practice can be an effective adjunct to exercise therapy in the rehabilitation of PFP in recreational female runners.

Project description:BackgroundPatellofemoral pain (PFP) impairs joint- and health-related quality of life and may be associated with knee osteoarthritis. We developed a novel, 2-phase, stepped-care approach for PFP, combining (1) self-directed web-based education and exercise therapy with (2) physiotherapist-supported education and exercise therapy. Physiotherapy sessions can be provided using 2 different modalities: face-to-face and telerehabilitation.ObjectiveThis study aims to (1) determine the feasibility of our stepped-care approach, (2) explore patient-reported outcomes following self-directed web-based education and exercise therapy in people with PFP (phase 1), and (3) estimate the differences in treatment effects between face-to-face and telerehabilitation to support further education and exercise therapy (phase 2) in those who had not completely recovered following self-directed care.MethodsPhase 1 involved 6 weeks of self-directed web-based education and exercise therapy. Phase 2 involved random allocation to a further 12 weeks of physiotherapist-led (up to 8 sessions) education and exercise therapy delivered face-to-face or via telerehabilitation to participants who did not rate themselves as completely recovered following phase 1. Feasibility indicators of process, adherence, and participant retention were collected as primary outcomes alongside patient-reported outcomes on Global Rating of Change and knee pain, disability, knee-related quality of life, pain catastrophism, kinesiophobia, and knee self-efficacy. All participants were assessed at baseline, 6 weeks, and 18 weeks.ResultsA total of 71 participants were screened to identify 35 participants with PFP to enter the study. Overall, 100% (35/35) and 88% (31/35) of the participants were followed up with at 6 and 18 weeks, respectively. In phase 1 of the study, participants accessed the My Knee Cap website for an average of 6 (7.5) days and performed the exercises for an average of 2.5 (3.6) times per week. A total of 20% (7/35) of the participants reported that they had completely recovered at 6 weeks. Furthermore, 93% (26/28) of the participants who were followed up and had not completely recovered at 6 weeks agreed to be enrolled in phase 2. No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome. The novel stepped-care approach was associated with marked improvement or complete recovery in 40% (14/35) of the participants following phase 1 and 71% (25/35) of the participants following phase 2.ConclusionsSelf-directed web-based education and exercise therapy for people with PFP is feasible, as noted by the high rate of participant retention and home exercise adherence achieved in this study. Furthermore, 20% (7/35) of people reported complete recovery at 6 weeks. Both face-to-face and telerehabilitation physiotherapy should be considered for those continuing to seek care, as there is no difference in outcomes between these delivery modes. Determining the efficacy of the stepped-care model may help guide more efficient health care for PFP.

Project description:IntroductionInsomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions.Methods and analysisA parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibility criteria will be randomised to receive direct access to fully automated online CBT-I or to an online PE programme. The primary outcome is change in insomnia severity immediately postintervention; secondary outcomes are change in daytime functioning and other sleep measures postintervention and at 6-month and 24-month follow-up. Objective data from national registries will be obtained at two time points (1 year and 2 years post-treatment), allowing a mirror image study of preintervention and postintervention rates of sick leave, and of medication and healthcare utilisation by condition.Ethics and disseminationThe study protocol was approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/134). Findings from the RCT will be disseminated in peer-reviewed publications and conference presentations. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to patient advocacy and other relevant organisations.Trial registration numberNCT02558647; Pre-results.

Project description:IntroductionOnline pain management programmes (PMP) have growing evidence as effective interventions for individuals with chronic pain (CP). Mindfulness-based stress reduction (MBSR) is a psychological intervention proven to be effective in the management of CP. There is also a large body of evidence for the efficacy of exercise in the management of CP however, there are limited studies combining both these interventions and none to date delivering a combined intervention in the form of an online PMP. This study aims to explore the acceptability and feasibility of delivering a combined MBSR and exercise online PMP for adults with CP, and will examine the feasibility of conducting a randomised controlled trial of a combined MBSR and exercise online programme compared with an online self-management guide.Methods and analysisA parallel-group, feasibility randomised controlled trial (RCT) will be conducted among participants in Ireland, which will include an embedded qualitative study. Seventy-five participants will complete an online consent form and be individually randomised to one of two groups. Group A will participate in live online MBSR and supervised exercise sessions (2 hours MBSR, 1 hour exercise) once a week for 8 weeks. Group B will receive access to an 8-week online self-management guide, released biweekly and containing eight self-directed modules. Analyses of the feasibility study will be descriptive and will address the outcomes relating to the feasibility and acceptability of the interventions and procedures of the study including recruitment and eligibility, data collection methods, intervention adherence, engagement and attrition rates, intervention acceptability and participants' subjective perceptions of the programmes. Comparisons of clinical treatment effects, using validated patient-reported outcome measures will be explored descriptively to consider the viability of investigating a combined online MBSR and exercise intervention in a future fully powered RCT.Ethics and disseminationThis study was approved by the Mater Misericordiae University Hospital Institutional Review Board (1/378/2124) and the University College Dublin Human Research Ethics Committee (LS-20-76-Deegan-Doody). Informed consent will be obtained from each participant prior to randomisation. The results of this feasibility study will be published in peer-reviewed academic journals and presented at national and international conferences.Trial registrationNCT04899622.

Project description:ObjectivesStress has deleterious effects on teachers' well-being and interactions with students. While in-person mindfulness programs have demonstrated benefits for teachers' mental health, in-person classes are often not feasible due to teachers' busy schedules. This study assessed four components of feasibility (implementation, demand, acceptability, and limited-efficacy testing) for an online mindfulness intervention for teachers.MethodA volunteer sample of 50 primary school teachers was recruited across three urban public schools and was offered a 9-week online mindfulness program (DeStress Monday at School). The program provided weekly mindfulness practices for (1) self-care and (2) classroom use to promote teacher and student stress management. Surveys and focus group discussions assessed program feasibility. Paired t-tests were used to evaluate pre-post changes in teacher well-being.ResultsMost participants had no technical problems, providing general support for implementation. Support for program demand was mixed; while 85% of participants used practices at least once, some never used practices, and over half used practices only 1-3 times. Those who used practices generally rated their acceptability favorably. Qualitative analyses showed significant pre-post improvements in work-related and overall stress, depressive and anxiety symptoms, and sleep; those who used practices reported more benefits than those who did not. Qualitative data corroborated these findings, with teachers describing improved stress- and emotion-management following program use.ConclusionsOur findings suggest mindfulness can be delivered online to teachers and may enhance mental health and wellness. Next steps include conducting more rigorous research with a control condition to better understand potential program impact.PreregistrationThis study is not preregistered.Supplementary informationThe online version contains supplementary material available at 10.1007/s12671-023-02142-3.

Dataset Information

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.

Background

Methods

Discussion

Trial registration

Publications

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.

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