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Effects of rehabilitation approaches for runners with patellofemoral pain: protocol of a randomised clinical trial addressing specific underlying mechanisms.

ABSTRACT: Patellofemoral pain (PFP) is highly prevalent in runners, and often leads to functional limitations and cessation of running. Training errors as well as decreased lower limb strength and control during running have all been associated with PFP. While strengthening and gait retraining are commonly used by clinicians, no randomised clinical trial has compared these modalities in runners with PFP. The primary objective of this randomised clinical trial will be to compare the effects of three rehabilitation programs targeting different key factors on symptoms and functional limitations of runners with PFP. The secondary objective will be to explore the factors leading to clinical improvement.We will conduct a single-blind randomised clinical trial to compare three different 8 week rehabilitation programs: Group 1 will receive education on symptoms management based on training modifications; Group 2 will receive an exercise program targeting lower limb strengthening and control in addition to the education component of Group 1; Group 3 will receive running gait retraining advice as well as the education component of Group 1. Sixty-nine runners with PFP will be recruited and will be seen by independent physiotherapists on five visits through 8 weeks. The primary outcome measure will be symptoms and functional limitations measured by the Knee Outcome Survey - Activities of Daily Living Scale questionnaire at baseline, and at the four, eight and 20 weeks follow-up. Secondary outcomes will include pain level measured using visual analog scales, and running mileage. Lower limb kinematics and kinetics during running, and isometric strength will also be evaluated at baseline and 8 weeks follow-up. The effects of rehabilitation programs on measures of symptoms and functional limitations will be assessed using a 2-way ANOVA (Groups x Time). Regression analyses will be used to identify if changes in running mechanics or strength are determinants of clinical success.Studies with a high level of evidence are needed to determine the best rehabilitation interventions for runners with PFP. This randomised clinical trial will be the first to compare programs targeting different key factors linked with PFP. Results may guide clinicians and improve their clinical outcomes when treating runners with PFP.ClinicalTrials.gov: NCT02352909. Registered on December 3, 2014.

SUBMITTER: Esculier JF

PROVIDER: S-EPMC4702381 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Effects of rehabilitation approaches for runners with patellofemoral pain: protocol of a randomised clinical trial addressing specific underlying mechanisms.

Esculier Jean-Francois JF Bouyer Laurent J LJ Dubois Blaise B Frémont Pierre P Moore Lynne L Roy Jean-Sébastien JS

BMC musculoskeletal disorders 20160106

<h4>Background</h4>Patellofemoral pain (PFP) is highly prevalent in runners, and often leads to functional limitations and cessation of running. Training errors as well as decreased lower limb strength and control during running have all been associated with PFP. While strengthening and gait retraining are commonly used by clinicians, no randomised clinical trial has compared these modalities in runners with PFP. The primary objective of this randomised clinical trial will be to compare the effe ...[more]

PMID: 26738470

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Project description:IntroductionRotator cuff tendinopathy (RCTe) is the most frequent cause of shoulder pain, resulting in considerable losses to society and public resources. Muscle imbalance and inadequate sensorimotor control are deficits often associated with RCTe. Kinesiotaping (KT) is widely used by clinicians for rehabilitation of RCTe. While previous studies have examined the immediate effects of KT on shoulder injuries or the effects of KT as an isolated method of treatment, no published study has addressed its mid-term and long-term effects when combined with a rehabilitation programme for patients with RCTe. The primary objective of this randomised controlled trial (RCT) will be to assess the efficacy of therapeutic KT, added to a rehabilitation programme, in reducing pain and disabilities in individuals with RCTe. Secondary objectives will look at the effects of KT on the underlying factors involved in shoulder control, such as muscular activity, acromiohumeral distance (AHD) and range of motion (ROM).Methods and analysisA single-blind RCT will be conducted. Fifty-two participants, randomly allocated to one of two groups (KT or no-KT), will take part in a 6-week rehabilitation programme. The KT group will receive KT added to the rehabilitation programme, whereas the no-KT group will receive only the rehabilitation programme. Measurements will be taken at baseline, week 3, week 6, week 12 and 6 months. Primary outcomes will be symptoms and functional limitations assessed by the Disabilities of the Arm, Shoulder and Hand questionnaire. Secondary outcomes will include shoulder ROM, AHD at rest and at 60° of abduction, and muscle activation during arm elevation. The added effects of KT will be assessed through a two-way analysis of variance for repeated measures.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Quebec Rehabilitation Institute of the Centre Integrated University Health and Social Services. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.Trial registration numberProtocol was registered at ClinicalTrials.gov (NCT02881021) on 25 August 2016. The WHO Trial Registration Data Set can also be found as an online supplementary file.

Project description:Introduction Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: ‘My Knee UK’ and ‘Group E-Rehab’. Methods and analysis This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The ‘My Knee UK’ intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the ‘Group E-Rehab’ intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care. Ethics and dissemination The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals. Trial registration number ISRCTN15564385.

Project description:BackgroundPatellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence-based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient-perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP.MethodsThis randomised, controlled, participant- and assessor-blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12-18 years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3 months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop-out rate. Secondary outcomes will evaluate knee-related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions, at 6 weeks and 3 months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between-group differences (with 95% confidence intervals) will be reported for secondary outcomes.DiscussionFindings of this study will inform the feasibility of a full-scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full-scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population.Trial registrationACTRN12619000957190 .

Project description:ObjectiveDetermine if a change in internal knee abduction angular impulse (KAAI) is related to pain reduction for runners with patellofemoral pain (PFP) by comparing lateral and medial wedge insole interventions, and increased KAAI and decreased KAAI groups.DesignRandomized controlled clinical trial (ClinicalTrials.gov ID# NCT01332110).SettingBiomechanics laboratory and community.PatientsThirty-six runners with physician-diagnosed PFP enrolled in the trial, and 27 were analyzed.InterventionsRunners with PFP were randomly assigned to either an experimental 3 mm lateral wedge or control 6 mm medial wedge group. Participants completed a biomechanical gait analysis to quantify KAAIs with their assigned insole, and then used their assigned insole for six-weeks during their regular runs. Usual pain during running was measured at baseline and at six-week follow-up using a visual analog scale. Statistical tests were performed to identify differences between wedge types, differences between biomechanical response types (i.e. increase or decrease KAAI), as well as predictors of pain reduction.Main outcome measuresPercent change in KAAI relative to neutral, and % change in pain over six weeks.ResultsClinically meaningful reductions in pain (>33%) were measured for both footwear groups; however, no significant differences between footwear groups were found (p = 0.697). When participants were regrouped based on KAAI change (i.e., increase or decrease), again, no significant differences in pain reduction were noted (p = 0.146). Interestingly, when evaluating absolute change in KAAI, a significant relationship between absolute % change in KAAI and % pain reduction was observed (R2 = 0.21; p = 0.030), after adjusting for baseline pain levels.ConclusionThe greater the absolute % change in KAAI during running, the greater the % reduction in pain over six weeks, regardless of wedge type, and whether KAAIs increased or decreased. Lateral and medial wedge insoles were similar in effectiveness for treatment of PFP.Clinical relevanceAltering KAAI should be a focus of future PFP research. Lateral wedges should be studied further as an alternative therapy to medial wedges for management of PFP.Trial registrationClinicalTrials.gov NCT01332110.

Project description:ObjectiveTo compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.DesignProspective, single blind, randomised clinical trial.SettingSingle centre trial within a community setting in Brisbane, Australia.Participants179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks' duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.InterventionsSix weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.Main outcome measuresGlobal improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.ResultsFoot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66, 99% confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.ConclusionWhile foot orthoses are superior to flat inserts according to participants' overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.Trial registrationAustralian Clinical Trials Registry ACTRN012605000463673 and ClinicalTrials.gov NCT00118521.

Project description:BackgroundSelf-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents.Methods/designThis study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months.DiscussionThis study is designed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy. If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective, it may serve as a basis for optimising the clinical pathway for those suffering from the condition, where specific emphasis can be placed on early diagnosis and early treatment.Trial registrationclinicaltrials.gov reference: NCT01438762.

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Effects of rehabilitation approaches for runners with patellofemoral pain: protocol of a randomised clinical trial addressing specific underlying mechanisms.

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Effects of rehabilitation approaches for runners with patellofemoral pain: protocol of a randomised clinical trial addressing specific underlying mechanisms.

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