Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001858319374 Date of Approval: 24/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Epidemiology and therapeutic interventions for patellofemoral pain in recreational cyclists
Official scientific title Epidemiology and therapeutic interventions for patellofemoral pain in recreational cyclists
Brief summary describing the background and objectives of the trial Cycling has increased in popularity, and has great potential for fitness and rehabilitation. However, studies have shown that cyclists are at risk for injuries. Cycling injuries are classified as either traumatic or overuse (overuse injuries in cyclists - OICs). Although research on the epidemiology of lower limb overuse injuries in cyclists is limited, knee pain, and specifically the patellofemoral pain (PFP) syndrome, is one of the most common lower limb OICs, and is the most likely cause of time lost in cyclists training and racing. PFP syndrome alone accounts for approximately 25% of reported OICs. The biomechanics of the patellofemoral joint complex during cycling and during functional movements, are the key to understanding the mechanism of PFP in cyclists. The principles of preventing and managing PFP in cyclists rely, firstly, on establishing a detailed anatomical and pathological diagnosis of the injury and, secondly, identifying the underlying internal (related to the cyclist) and external (related to the bicycle and the environment) risk factors associated with the PFP in cyclist. Neither the epidemiology of PFP, nor the independent risk factors associated with PFP, in recreational cyclists have been well studied. The aims of the study are to measure the prevalence of, identify risk factors for, and test the effectiveness of two treatment interventions for patellofemoral pain (PFP) in recreational cyclists. This PhD study has four objectives, which will be addressed in two parts. In Part 1 we will measure the lifetime prevalence and severity of PFP in recreational cyclists (objective 1), and identify selected factors (demographics, years of training, history of chronic disease and medication use) in the same cohort of cyclists with self-reported PFP (objective 2). Part 2 will be a laboratory based experimental study to identify additional selected biomechanical and lower limb functional risk factors for PFP (objective 3), and then test the effectiveness of two treatment interventions for PFP in recreational cyclists, using a randomised controlled clinical trial (RCT) design (objective 4).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied patellofemoral pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2020
Actual trial start date
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Cycling kinematics standard treatment group Once off adjusting of the Seat / Cleat to obtain an optimal Knee Angle during cycling. The two aspects of knee kinematics will be optimised by systematically adjusting the seat and cleat parameters to a: 1. knee flexion angle of 25°-35° with the crank at 180° 2. frontal plane deviation of patella <30mm during the pedal cycle Six weeks The biomechanical interventions will entail starndard management to correct knee kinematics (knee medio-lateral movement and knee flexion angles) by adjusting saddle height, anteroposterior saddle position and cleat position, in that order. 50 Active-Treatment of Control Group
Experimental Group Combin correction of cycling kinematics and supervised physical exercise program intervention group Standard treatment: Once off adjusting of the Seat / Cleat to obtain an optimal Knee Angle during cycling. The two aspects of knee kinematics will be optimized by systematically adjusting the seat and cleat parameters to a: 1. knee flexion angle of 25°-35° with the crank at 180° 2. frontal plane deviation of patella <30mm during the pedal cycle Added intervention: The physical rehabilitation interventions will entail a six week physical exercise program. In the first two weeks, participants will perform rehabilitation sessions twice a week with at least two days of rest in between each session. This will be progressed to three times per week, with at least one rest day in between each session. The participants will be required to complete 16 supervised exercise sessions in the six weeks to measure compliance (% sessions completed). Six weeks The intervention will entail the following: 1) standard treatment by correcting knee kinematics, as in the active-intervention control group (knee medio-lateral movement and knee flexion angles) by adjusting saddle height, anteroposterior saddle position and cleat position, in that order, and 2) an additional physical rehabilitation intervention that will be standardized and will entail a six week supervised (online and visits to the facility) physical exercise program with a built in progression model. In the first two weeks, participants will perform rehabilitation sessions twice a week with at least two days of rest in between each session. This will be progressed to three times per week, with at least one rest day in between each session. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
General study inclusion criteria:  18 years of age and older  Individuals where their current predominant sport / physical activity is cycling (indoor, road or MTB)  Cyclists with at least 12 months experience of regular cycling  Cycling at least an average of 30km/week over the past 12 months.  No current pain (in any anatomical area other than the knee) during cycling, that is severe enough to interfere with the cyclist’s ability to cycle, or stop them from training or competing (≥5/10 on VAS) Specific inclusion criteria for the PFP group:  Pain around the anterior aspect of the knee, insidious onset and no evidence of trauma  Minimum of four weeks history of anterior knee pain (pain, 3/> of 10)  Present with at least one of the following: o Pain around or behind the patella, which is aggravated by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee (e.g. squatting, stair ambulation, jogging / running, hopping / jumping, cycling). o Crepitus or grinding sensation emanating from the patellofemoral joint during knee flexion movements o Tenderness on patellar facet palpation o Small effusion  Pain on sitting, rising on sitting, or straightening the knee following sitting Pain present on at least 1 clinical test (vastus medialis coordination test, patellar apprehension test, eccentric step test, Waldron’s test (Phases I and II), Clarke’s test, standard step-down test, lateral step down test, single-leg squat)  Current pain (≥5/10 on VAS), in any anatomical area other than the knee, during cycling that is severe enough to interfere with the cyclists ability to, and even stop them from, training or competing.  Clinical, radiographic, or MRI findings indicative of other specific knee pathology other than PFP in the last 12 month: including meniscal, ligament, or cartilage injury, as well as osteoarthritis (stage 3 and 4), epiphysitis, significant knee joint effusion, or recurrent patellar subluxation or dislocation in the last 12 months.  Previous surgery to the knee joint within the past 3 months.  Previous acute trauma to the knee joint with an effect on the presenting clinical condition within the previous 3 months Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/11/2019 Faculty of Health Sciences Research Ethics Committee of the University of Pretoria
Ethics Committee Address
Street address City Postal code Country
University of Pretoria, Tswelopele Building, Room 4-60, Level 4, Gezina Pretoria 0031 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale [0 (no pain) to 10 (worst pain possible)]. VAS-C pain during cycling (0-10) The VAS-C scale will be emailed to the participants of the injured group to be completed weekly for a period of six weeks.
Secondary Outcome Oslo Sports Trauma Research Centre (OSTRC) questionnaire Score out of 100 The OSTRC questionnaire will be emailed to the participants of the injured group to be completed weekly for a period of six weeks.
Secondary Outcome Medial or lateral deviation of the knee during cycling The medial or lateral deviation of the knee during cycling will be evaluated at the six weeks post-intervention follow up during the cycling biomechanics assessment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SEMLI of the University of Pretoria Burnett Street, Hillcrest Campus, University of Pretoria, Hatfield, Pretoria, South Africa. Pretoria 0028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Pretoria. SEMLI Burnett Street, Hatfield, LC de Villiers Pretoria 0028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SEMLI at the University of Pretoria Burnett Street, Hillcrest Campus, University of Pretoria, Hatfield, Pretoria, South Africa. Pretoria 0028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
SEMLI University of Pretoria Burnett Street, Hatfield, LC de Villiers Pretoria 0028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francois Du Toit fcdutoit85@gmail.com +27124206033 Burnett Street, Hillcrest Campus, University of Pretoria, Hatfield, Pretoria, South Africa.
City Postal code Country Position/Affiliation
Pretoria 0028 South Africa Biokineticist and PhD student
Role Name Email Phone Street address
Public Enquiries Francois Du Toit fcdutoit85@gmail.com +27124206033 Burnett Street, Hillcrest Campus, University of Pretoria, Hatfield, Pretoria, South Africa.
City Postal code Country Position/Affiliation
Pretoria 0028 South Africa Biokineticist and PhD student
Role Name Email Phone Street address
Scientific Enquiries Francois Du Toit fcdutoit85@gmail.com +27124206033 Burnett Street, Hillcrest Campus, University of Pretoria, Hatfield, Pretoria, South Africa.
City Postal code Country Position/Affiliation
Pretoria 0028 South Africa Biokineticist and PhD student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All collected IPD and all IPD that underlie results in a publication Clinical Study Report,Informed Consent Form Start April 2024 End April 2025 Controlled access. All data requests will need to be addressed to the Primary Investigator via email (fcdutoit85@gmail.com) and the Primary Investigator will decide who gets access to the data. This will be based on the quality and purpose of the request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information