2022
O’Sullivan, Isobel C.; da Costa, Nathalia Cordeiro; Smith, Melinda M. Franettovich; Vicenzino, Bill; Crossley, Kay M.; Kamper, Steven J.; van Middelkoop, Marienke; Menz, Hylton B.; Tucker, Kylie; O’Leary, Karina T.; Collins, Natalie J.
Adolescent perspectives on participating in a feasibility trial investigating shoe inserts for patellofemoral pain Journal Article
In: J Foot Ankle Res, vol. 15, no. 1, 2022, ISSN: 1757-1146.
Abstract | Links | BibTeX | Tags: Knee Pain, Orthopedics and Sports Medicine
@article{O’Sullivan2022,
title = {Adolescent perspectives on participating in a feasibility trial investigating shoe inserts for patellofemoral pain},
author = {Isobel C. O’Sullivan and Nathalia Cordeiro da Costa and Melinda M. Franettovich Smith and Bill Vicenzino and Kay M. Crossley and Steven J. Kamper and Marienke van Middelkoop and Hylton B. Menz and Kylie Tucker and Karina T. O’Leary and Natalie J. Collins},
url = {https://painsmart-education.sydney.edu.au/wp-content/uploads/2024/03/Adolescent-perspectives-on-participating-in-a-.pdf, PDF},
doi = {10.1186/s13047-022-00537-4},
issn = {1757-1146},
year = {2022},
date = {2022-12-00},
urldate = {2022-12-00},
journal = {J Foot Ankle Res},
volume = {15},
number = {1},
publisher = {Wiley},
abstract = {<jats:title>Abstract</jats:title><jats:sec>
<jats:title>Background</jats:title>
<jats:p>Patellofemoral pain (PFP) affects one-quarter of adolescents, yet there are few evidence-informed recommendations to treat PFP in this population. HAPPi Kneecaps! is a randomised, controlled, participant- and assessor-blind, parallel-group feasibility trial of shoe inserts for adolescents with PFP. The aim of this qualitative study was to explore adolescents’ perspectives of participating in HAPPi Kneecaps!.</jats:p>
</jats:sec><jats:sec>
<jats:title>Methods</jats:title>
<jats:p>All 36 adolescents with PFP from the HAPPi Kneecaps! study were invited to participate in semi-structured interviews. We used a descriptive qualitative methodology underpinned by a relativist framework to investigate adolescents’ perspectives on participating in the trial. Inductive thematic analysis was used to examine patterns regarding how each adolescent experienced the HAPPi Kneecaps! study within their social, cultural, and historical contexts.</jats:p>
</jats:sec><jats:sec>
<jats:title>Results</jats:title>
<jats:p>14 out of 36 HAPPi Kneecaps! participants provided consent and participated in interviews (12 females; mean [SD] age 14.9 [2.4] years). Overall, most adolescents responded positively when discussing their experience, such as improvements in their knee pain and satisfaction with how the study was run. Major themes that were generated from the analysis and feedback were: (1) shoe inserts require little effort to use; (2) perceptions of the program were generally positive; (3) participation in the trial could be made easier; (4) warm weather matters; and (5) life happens.</jats:p>
</jats:sec><jats:sec>
<jats:title>Conclusion</jats:title>
<jats:p>Adolescents with PFP who participated in the HAPPi Kneecaps! study found that shoe inserts were easy to wear. Most adolescents experienced an improvement in their symptoms and enhanced participation in sport and exercise. Adolescents with PFP prefer an option for warmer climates (e.g. flip flops or sandals), access to online logbooks, and clinicians who are easily accessible.</jats:p>
</jats:sec><jats:sec>
<jats:title>Trial registration</jats:title>
<jats:p>Australian New Zealand Clinical Trials Registry (ANZCTR): <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377749&isReview=true">ACTRN12619000957190</jats:ext-link>. Date registered: 8/07/2019.</jats:p>
</jats:sec>},
keywords = {Knee Pain, Orthopedics and Sports Medicine},
pubstate = {published},
tppubtype = {article}
}
<jats:title>Background</jats:title>
<jats:p>Patellofemoral pain (PFP) affects one-quarter of adolescents, yet there are few evidence-informed recommendations to treat PFP in this population. HAPPi Kneecaps! is a randomised, controlled, participant- and assessor-blind, parallel-group feasibility trial of shoe inserts for adolescents with PFP. The aim of this qualitative study was to explore adolescents’ perspectives of participating in HAPPi Kneecaps!.</jats:p>
</jats:sec><jats:sec>
<jats:title>Methods</jats:title>
<jats:p>All 36 adolescents with PFP from the HAPPi Kneecaps! study were invited to participate in semi-structured interviews. We used a descriptive qualitative methodology underpinned by a relativist framework to investigate adolescents’ perspectives on participating in the trial. Inductive thematic analysis was used to examine patterns regarding how each adolescent experienced the HAPPi Kneecaps! study within their social, cultural, and historical contexts.</jats:p>
</jats:sec><jats:sec>
<jats:title>Results</jats:title>
<jats:p>14 out of 36 HAPPi Kneecaps! participants provided consent and participated in interviews (12 females; mean [SD] age 14.9 [2.4] years). Overall, most adolescents responded positively when discussing their experience, such as improvements in their knee pain and satisfaction with how the study was run. Major themes that were generated from the analysis and feedback were: (1) shoe inserts require little effort to use; (2) perceptions of the program were generally positive; (3) participation in the trial could be made easier; (4) warm weather matters; and (5) life happens.</jats:p>
</jats:sec><jats:sec>
<jats:title>Conclusion</jats:title>
<jats:p>Adolescents with PFP who participated in the HAPPi Kneecaps! study found that shoe inserts were easy to wear. Most adolescents experienced an improvement in their symptoms and enhanced participation in sport and exercise. Adolescents with PFP prefer an option for warmer climates (e.g. flip flops or sandals), access to online logbooks, and clinicians who are easily accessible.</jats:p>
</jats:sec><jats:sec>
<jats:title>Trial registration</jats:title>
<jats:p>Australian New Zealand Clinical Trials Registry (ANZCTR): <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377749&isReview=true">ACTRN12619000957190</jats:ext-link>. Date registered: 8/07/2019.</jats:p>
</jats:sec>
2021
O’Sullivan, Isobel C.; Crossley, Kay M.; Kamper, Steven J.; van Middelkoop, Marienke; Vicenzino, Bill; Smith, Melinda M. Franettovich; Menz, Hylton B.; Smith, Anne J.; Tucker, Kylie; O’Leary, Karina T.; Costa, Nathalia; Collins, Natalie J.
In: J Foot Ankle Res, vol. 14, no. 1, 2021, ISSN: 1757-1146.
Abstract | Links | BibTeX | Tags: Knee Pain, Orthopedics and Sports Medicine
@article{O’Sullivan2021,
title = {HAPPi Kneecaps! A double-blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study},
author = {Isobel C. O’Sullivan and Kay M. Crossley and Steven J. Kamper and Marienke van Middelkoop and Bill Vicenzino and Melinda M. Franettovich Smith and Hylton B. Menz and Anne J. Smith and Kylie Tucker and Karina T. O’Leary and Nathalia Costa and Natalie J. Collins},
url = {https://painsmart-education.sydney.edu.au/wp-content/uploads/2024/03/HAPPi-Kneecaps_A-double-blind-randomised_Phase-II-feasibility-study.pdf, PDF},
doi = {10.1186/s13047-021-00498-0},
issn = {1757-1146},
year = {2021},
date = {2021-12-00},
urldate = {2021-12-00},
journal = {J Foot Ankle Res},
volume = {14},
number = {1},
publisher = {Wiley},
abstract = {<jats:title>Abstract</jats:title><jats:sec>
<jats:title>Background</jats:title>
<jats:p>Patellofemoral pain (PFP) affects one-third of adolescents and can persist into adulthood, negatively impacting health and quality of life. Foot orthoses are a recommended treatment for adults with PFP, but have not been evaluated in adolescents. The primary objective was to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating effects of contoured, prefabricated foot orthoses on knee pain severity and patient-perceived global change, compared to flat insoles. The secondary objective was to describe outcomes on a range of patient-reported outcome measures.</jats:p>
</jats:sec><jats:sec>
<jats:title>Methods</jats:title>
<jats:p>We recruited adolescents aged 12–18 years with PFP of ≥2 months duration into a double-blind, randomised, parallel-group feasibility trial. Participants were randomised to receive prefabricated contoured foot orthoses or flat shoe insoles, and followed for 3 months. Participants and outcome assessors were blinded to group allocation. Primary outcomes were feasibility of a full-scale RCT (number of eligible/enrolled volunteers; recruitment rate; adherence with the intervention and logbook completion; adverse effects; success of blinding; drop-out rate), and credibility and expectancy of interventions. Secondary outcomes were patient-reported measures of pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions.</jats:p>
</jats:sec><jats:sec>
<jats:title>Results</jats:title>
<jats:p>36 out of 279 (12.9%) volunteers (27 female, mean (SD) age 15 (2) years, body mass 60 (13) kg) were eligible and enrolled, at a recruitment rate of 1.2 participants/week. 17 participants were randomised to receive foot orthoses, and 19 to flat insoles. 15 participants returned logbooks; 7/15 (47%) adhered to the intervention. No serious adverse events were reported. 28% (10/36, 4 pandemic-related) of participants dropped out before 3 months. Blinding was successful. Both groups found the inserts to be credible.</jats:p>
</jats:sec><jats:sec>
<jats:title>Conclusions</jats:title>
<jats:p>Based on a priori criteria for feasibility, findings suggest that a full-scale RCT comparing contoured foot orthoses to flat insoles in adolescents with PFP would not be feasible using the current protocol. Prior to conducting a full-scale RCT, feasibility issues should be addressed, with protocol modifications to facilitate participant retention, logbook completion and shoe insert wear.</jats:p>
</jats:sec><jats:sec>
<jats:title>Trial registration</jats:title>
<jats:p>Australian New Zealand Clinical Trials Registry (ANZCTR): <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377749">ACTRN12619000957190</jats:ext-link>. Date registered: 8/07/2019.</jats:p>
</jats:sec>},
keywords = {Knee Pain, Orthopedics and Sports Medicine},
pubstate = {published},
tppubtype = {article}
}
<jats:title>Background</jats:title>
<jats:p>Patellofemoral pain (PFP) affects one-third of adolescents and can persist into adulthood, negatively impacting health and quality of life. Foot orthoses are a recommended treatment for adults with PFP, but have not been evaluated in adolescents. The primary objective was to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating effects of contoured, prefabricated foot orthoses on knee pain severity and patient-perceived global change, compared to flat insoles. The secondary objective was to describe outcomes on a range of patient-reported outcome measures.</jats:p>
</jats:sec><jats:sec>
<jats:title>Methods</jats:title>
<jats:p>We recruited adolescents aged 12–18 years with PFP of ≥2 months duration into a double-blind, randomised, parallel-group feasibility trial. Participants were randomised to receive prefabricated contoured foot orthoses or flat shoe insoles, and followed for 3 months. Participants and outcome assessors were blinded to group allocation. Primary outcomes were feasibility of a full-scale RCT (number of eligible/enrolled volunteers; recruitment rate; adherence with the intervention and logbook completion; adverse effects; success of blinding; drop-out rate), and credibility and expectancy of interventions. Secondary outcomes were patient-reported measures of pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions.</jats:p>
</jats:sec><jats:sec>
<jats:title>Results</jats:title>
<jats:p>36 out of 279 (12.9%) volunteers (27 female, mean (SD) age 15 (2) years, body mass 60 (13) kg) were eligible and enrolled, at a recruitment rate of 1.2 participants/week. 17 participants were randomised to receive foot orthoses, and 19 to flat insoles. 15 participants returned logbooks; 7/15 (47%) adhered to the intervention. No serious adverse events were reported. 28% (10/36, 4 pandemic-related) of participants dropped out before 3 months. Blinding was successful. Both groups found the inserts to be credible.</jats:p>
</jats:sec><jats:sec>
<jats:title>Conclusions</jats:title>
<jats:p>Based on a priori criteria for feasibility, findings suggest that a full-scale RCT comparing contoured foot orthoses to flat insoles in adolescents with PFP would not be feasible using the current protocol. Prior to conducting a full-scale RCT, feasibility issues should be addressed, with protocol modifications to facilitate participant retention, logbook completion and shoe insert wear.</jats:p>
</jats:sec><jats:sec>
<jats:title>Trial registration</jats:title>
<jats:p>Australian New Zealand Clinical Trials Registry (ANZCTR): <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377749">ACTRN12619000957190</jats:ext-link>. Date registered: 8/07/2019.</jats:p>
</jats:sec>
2017
Swain, Michael S.; Kamper, Steven J.; Maher, Chris G.; Latimer, Jane; Broderick, Carolyn; McKay, Damien; Henschke, Nicholas
Short‐term Clinical Course of Knee Pain in Children and Adolescents: A Feasibility Study Using Electronic Methods of Data Collection Journal Article
In: Physiotherapy Res Intl, vol. 22, no. 4, 2017, ISSN: 1471-2865.
Abstract | Links | BibTeX | Tags: Knee Pain, Physical Therapy, Sports Therapy and Rehabilitation
@article{Swain2016,
title = {Short‐term Clinical Course of Knee Pain in Children and Adolescents: A Feasibility Study Using Electronic Methods of Data Collection},
author = {Michael S. Swain and Steven J. Kamper and Chris G. Maher and Jane Latimer and Carolyn Broderick and Damien McKay and Nicholas Henschke},
url = {https://painsmart-education.sydney.edu.au/wp-content/uploads/2024/03/Short-term-Clinical.A-Feasibility-Study-Using-Electronic-Methods-of-Data-Collection.pdf, PDF},
doi = {10.1002/pri.1669},
issn = {1471-2865},
year = {2017},
date = {2017-10-00},
urldate = {2017-10-00},
journal = {Physiotherapy Res Intl},
volume = {22},
number = {4},
publisher = {Wiley},
abstract = {<jats:title>Abstract</jats:title><jats:sec><jats:title>Background and Purpose</jats:title><jats:p>Musculoskeletal disorders, such as knee pain, are common in children and adolescents, but there is a lack of high quality research that evaluates the clinical course of these conditions. The objective of this study was to evaluate the feasibility of conducting a prospective study of children and adolescents with knee pain using electronic methods of data collection.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Children and adolescents with knee pain that presented to primary care physiotherapy clinics were enrolled and followed‐up on a weekly basis via short messaging service (SMS) until their knee pain had recovered (i.e. two consecutive weeks of no pain). Feasibility was assessed in terms of recruitment, retention and response rates to SMS and an online questionnaire. Baseline and 6‐month follow‐up measures included pain, disability, physical function, physical activity and health related quality of life. Kaplan–Meier survival analysis was used to estimate the median time to knee pain recovery.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Thirty participants (mean age 13.0 ± 2.2 years, 53% boys) were recruited over 26 months. The overall response rate to weekly SMS follow‐up was 71.3% (809 received/1135 sent). One third of participants stopped responding to SMS prior to recovery, and these participants typically had a much lower response rate during the time they remained in the study. At 6‐month follow‐up, 80% of the cohort completed the final online questionnaire, and 29% of participants still reported current knee pain (≥1/10 VAS). The median time for knee pain recovery was 8 weeks (95%CI: 5, 10).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Electronic data collection alone seems insufficient to track pain recovery in young people and may need to be supplemented with more traditional data collection methods. Researchers should consider further measures to address slow recruitment rates and high attrition when designing large prospective studies of children and adolescents in the future. Copyright © 2016 John Wiley & Sons, Ltd.</jats:p></jats:sec>},
keywords = {Knee Pain, Physical Therapy, Sports Therapy and Rehabilitation},
pubstate = {published},
tppubtype = {article}
}