The purpose of the present project is to investigate if the restitution time from loading in an exercise-based 12 weeks rehabilitation regime for patellar tendinopathy influences the clinical outcome, tendon structure and function. The investigators hypothesize that greater restitution from loading (1 exercise day per week) will yield a greater positive clinical outcome, and tissue structure and function in patients with patellar tendinopathy compared to less restitution (3 exercise days per week), when impact activities are restricted in both groups.
This study is designed as a prospective, randomized, controlled, open label, superiority trial with a two-group parallel design and primary endpoint after 12 weeks. The study has two phases; The first phase includes the main trial in which a 12-week intervention period will be undertaken to test the hypotheses in patients with chronic patellar tendinopathy (symptoms \> 3 months). At 12 weeks, a smaller group of patients (responding and not-responding to the 12-week intervention period) will be offered to participate in sub-study 1. In this explorative cross-sectional study, the feasibility of mapping brain structure, function and metabolism using Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique in chronic patellar tendinopathy patients will be assessed. The second phase in the main study includes the follow-up from 12 week to the secondary endpoint at 52 weeks after baseline. During this period the participants will be monitored via questionnaires for treatment satisfaction and improvements at 4-week intervals. What treatment and the duration of treatment patients will receive in this phase is based on the concept of personalized medicine. We expect the majority of patient to continue in the group with loading-based intervention. A smaller group of the 52 patients from the main study is expected to be included in sub-study two. Sub study two is designed as an observational cohort study. In this sub study, patients reporting no self-evaluated improvement after 12 weeks of loading-based treatment will be asked to be part of a group receiving corticosteroid injection treatment followed by continued exercise-based treatment and avoidance of impact loading. The cohort will further include patients that after week 20, 24, 28, 32, 36 and 40 respond that they have not achieved their Patient Acceptable Symptom State (PASS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
The exercise will be started at 60% of 1 repetition maximum (RM) and progressed to 75% of 1 RM during the first 3 weeks and maintained throughout the intervention period. The exercise will be performed slowly (6 s/ repetition).
Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg Hospital
Copenhagen, NV, Denmark
Patient perception VISA-P
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
Time frame: Change from baseline at week 12
Patient perception VISA-P secondary
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
Time frame: Change from baseline at week 16 and 52
Patient perception VISA-P truncated
Change in Victorian Institute of Sports Assessment - patella (VISA-P) truncated score. The truncated score only including questions 2-6, with a maximum score of 50. Lower scores indicating more symptoms and limitations of function and activity.
Time frame: Change from baseline at week 12, 16 and 52
Self-reported pain (NRS) - Preferred sport
Change in pain rating on an 11 point numeric rating scale (NRS) during preferred sport, with 10 being the worst imaginable pain and 0 denoting no pain.
Time frame: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported pain (NRS) - Rest
Change in pain rating on an 11 point numeric rating scale (NRS) during rest, with 10 being the worst imaginable pain and 0 denoting no pain.
Time frame: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
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Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Self-reported pain (NRS) - Daily activities
Change in pain rating on an 11 point numeric rating scale (NRS) during daily activities, with 10 being the worst imaginable pain and 0 denoting no pain.
Time frame: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported improvement (GROC)
Self-reported improvement after treatment will be evaluated by the Global Rating of change (GROC) on a 7-point Likert scale ranging from 'much improved' to 'much worse'.
Time frame: Change from baseline at week 12, 16 and 52.
Sports participation
Number of sports participation hours per week (training and competition).
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Sports types
Typer of sports performed.
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Sports intensity
Intensity of sport performed registred in a self-reported questianaire and categorized as; light, moderate or vigorous.
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported satisfaction (PASS)
Self-evaluated satisfaction with treatment result will be evaluated by Patient Acceptable Symptom State (PASS) on a 5-point Likert scale ranging from 'very satisfied' to 'very unsaticfied'
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Treatment received
Registration of any additive treatment received from last follow-up measured with self-reported questionnaire.
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Care-seeking behavior
Registration of any additive care-seeking behavior from last follow-up measured with self-reported questionnaire.
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
The single-leg decline squat (SLDS) will be used to assess pain during function
Participants performed a decline squat on a 25°decline board and reported pain using an 11 point numeric rating scale (NRS) upon completion, with 10 being the worst imaginable pain and 0 denoting no pain.
Time frame: Change from baseline at week 12 and 52.
Muscle strength
Maximal muscle strength is obtained during standardized maximal voluntary contractions.
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon thickness
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon neovascularization
Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization.
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon microvascularisation
B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation.
Time frame: Change from baseline at week 12 and 52.
Counter movement Jump height
Jump height during Counter movement Jump test will be used to assess patellar tendinopathy caused functional deficits.
Time frame: Change from baseline at week 12 and 52.