Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05713656 |
| Other study ID # |
2023-3036 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
November 2022 |
| Source |
Ciusss de L'Est de l'Île de Montréal |
| Contact |
Simon Lafrance, PT, MSc |
| Phone |
4388633995 |
| Email |
simon.lafrance.1[@]umontreal.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background Cycling is a very popular activity and has various health benefits. Knee pain is
very common among recreational cyclists and often limits cyclists to perform their sport.
Physiotherapy care including a bike fit is often a recommended treatment for cyclists with
knee pain.
Objective The aim of this proposal is to prospectively describe physiotherapy care (bike fit,
education and exercises) and evaluate change in knee-related pain and disability among
recreational cyclists with knee pain.
Methods In this prospective observational study, 70 recreational cyclists consulting for knee
pain at Physiovélo will be recruited. Physiovélo is a physiotherapy clinic specialized in
bike fitting and in the assessment of cyclists with musculoskeletal disorders. Main findings
from the bike fit assessment as well as interventions provided in terms of bike fit
adjustment, education, advice and exercises will be collected. Various outcomes related to
cycling such as cycling distance per week will also be collected. The primary outcome will
knee pain during cycling measured with the numerical pain rating scale (NPRS, 0-10).
Secondary outcomes will include disability measured with the Knee Outcome Survey of the
Activities of Daily Living Scale (KOS-ADLS) and with a modified version of the Knee Outcome
Survey Sports Activities Scale (KOS-SAS) for cyclist. Satisfaction with care will be measured
with the visit-specific satisfaction questionnaire (VSQ-9). Adverse events related to the
interventions will be collected. Outcomes will be collected on initial assessment and at 4
and 12 weeks after the consultation. Intention-to-treat analyses will be performed.
Description:
Background With the COVID-19 pandemic, cycling became more popular in many Western countries
including Canada. Despite all its health benefits, cycling is often associated with
non-traumatic injuries. Among these, knee pain represents one of the most prevalent injuries
that leads to stop cycling and to seek medical assistance. Knee pain can be due to changes in
cycling parameters and/or positioning on the bicycle.
Bike fitting was first destined to the professional cyclist and has really taken off in the
glorious years of Lance Armstrong in the 1990s. In the 2000s, with the increase in popularity
of recreational cycling, the access to a bike fit became more accessible for the population
and is commonly used to decrease pain, discomfort and fatigue while cycling. Howsoever, the
bike fit done in clinics by a physiotherapist is quite new. During these sessions, the
physiotherapist will assess the cyclist's physical condition and capacity, training habits
and fitting on the bike. In terms of interventions, the physiotherapist will optimize the
cyclist position on the bike, while providing education and prescribe exercises when
indicated.
Since 2015, the Physiovélo clinic has been a pioneer in the care of cyclists in physiotherapy
in Quebec. Through constant growth over the past few years, the clinic served more than 1000
cyclists in 2021. Our physiotherapy service is distinguished by the evaluation and cycling
positioning that allow patients to be received with their own bike in order to address
cycling pathologies at the source by ensuring optimal adjustments on the bike.
However, the clinical efficacy of a bike fit among cyclists with knee pain has yet to be
formally evaluated.
Objectives and Hypothesis The aim of this proposal is to prospectively describe physiotherapy
care (bike fit, education and exercises) and evaluate change in knee-related pain and
disability among recreational cyclists with knee pain.
Our hypothesis is that significant improvement in knee-related pain and disability will be
observed at 1 and 3 months after physiotherapy care (including a bike fit) among recreational
cyclists.
Methods Study design Prospective observational longitudinal study. Study settings This study
will take place at Physiovélo, a physiotherapy clinic specialized in bike fitting and in the
assessment of cyclists with musculoskeletal disorders located in Longueuil, QC. Three
physiotherapists with certification ranging from BikePT bronze to gold are currently working
at Physiovélo. They assess more than 1000 cyclists per year, in which about a third are
presenting for knee pain.
Physiovélo is already fully equipped to address cyclists' problems on the bike and outside
the bike. There is a vast inventory of bike parts and tools to ensure a complete optimization
of the bike at the end of the bike fit. There are also two different platforms with home
trainers that permit the physiotherapist to work in an efficient and ergonomic position.
Those platforms are equipped with a dynamic balance system, specially developed for bike fit
at Physiovélo. This device permits the evaluation of the center of mass of the cyclist in
correlation with the center of mass of the bike.
Participants Consecutive cyclists with knee pain while cycling consulting for a BikeFit at
Physiovélo for the first time. To be included, cyclists must be at least 18 years old, be
legally able to consent and understand and speak French or English.
Data collection Prior to being assessed, eligible participants will answer a questionnaire
covering sociodemographic characteristics, cycling data such as cycling distance, frequency
per week and mean cadence and knee-related pain and disability questionnaires. Cycling data
(distance, frequency and mean cadence), treatment compliance, cointerventions and
knee-related pain and disability outcomes will also be collected at 4 and 12 weeks after the
assessment. Based on their initial assessment, the physiotherapist will complete a
standardized form indicating their diagnoses and treatment plan in terms of bike adjustment,
education, advice, exercises, and other relevant physiotherapy interventions. All data will
be collected through the Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CRHMR) REDCap
data collection portal which uses a Transport Layer Security (SLL/TLS) encryption to secure
data. For participants who prefer to fill out the questionnaires in a paper format, the
results will be transcribed into the REDCap data collection portal by a member of the
research team.
Outcome measures The primary outcomes will be worst, least, and average knee pain during the
last bike ride as measured with the numerical pain rating scale (NPRS, 0-10). As secondary
outcomes, current knee pain will be measured with the NPRS, disability will be measured with
the Knee Outcome Survey of the Activities of Daily Living Scale (KOS-ADLS) which is valid,
reliable and translated in French. A modified version of the Knee Outcome Survey Sports
Activities Scale (KOS-SAS), The KOS-SAS will be modified and adapted to cyclists, including
questions on pain and pain-related disability during cycling. It will be translated in French
in a back-translation method. A 11-point Global Rating of Change (GRoC) score will also be
used to measure global perceived imporvement. The MCID for a 11-point GRoC is 2 points.
Satisfaction with care will be measured with the visit-specific satisfaction questionnaire
(VSQ-9). Adverse events related to the interventions will be collected.
Statistical analyses A repeated measure ANOVA will be used to determine whether outcomes
differ across time points (baseline, 4 and 12 weeks). Sphericity will be tested with
Mauchly's test. If sphericity is rejected (variances of the difference are not equal),
correction will be used to determine if repeated measures ANOVA test is statistically
significant. Multiple regression will be performed to assess the impact of independent
variables (sociodemographic characteristics, physiotherapy care, treatment compliance,
cointerventions and cycling data) on dependent variables (pain and disability). Alpha levels
will be set at 0.05. All analyses will be carried out using the SPSS software (IBM Corp.
Released 2021. IBM SPSS Statistics for Windows, Version 27.0) and the Excel software
(Microsoft Corporation. 2018. Microsoft Excel for Windows).
Sample Size The sample size required is based on the primary outcome measure, the NPRS. The
NPRS has an estimated minimum clinically important difference of 1.5 points, and an estimated
SD of 3 points, which correspond to an half a SD effect size. The considered parameters are
0.05 for a type I error (α) with a power of 0.80 (1-β). For an analysis of variance (ANOVA)
two-sided, the sample size required is 70 participants. This sample also accounts for a
potential 10% loss to follow up at 12 weeks. Sample size calculation was performed with the
Excel software using the sample size formula as described by Zhong.
Ethics, Consent and Confidentiality Ethics approval will be obtained from the Comité
d'éthique de la recherche du CIUSS de l'Est-de-l'Île-de-Montréal. Participants will need to
sign the information and consent form before enrollment in the project. The information and
consent form will be presented and electronically signed on the REDCap platform. Electronic
and multimedia elements including an explanatory video, dictionary and glossary will be
available on the REDCap platform to support participants in the consent process. Members of
the research team will be available to discuss with the participants on the phone if needed.
Paper version of the information and consent form will also be available for participants who
do not have access to a computer or for participants who prefer the paper version. In these
circumstances, the information and consent form will be presented to each participant on the
phone and will be sent by mail. Participants will need to return the signed consent page by
mail. Nominal data will be kept in an electronic file protected by a password and separately
from all other data. Participants will be attributed an identification code. Data will be
encrypted and only the members of the research team whose functions require access to this
information will be allowed access. All research personnel will sign confidentiality
agreements.
