Influence of Restitution Time in Treatment of Patellar Tendinopathy

Not Applicable

Active, not recruiting

• Conditions: Patellar Tendinopathy; Jumper's Knee
• Interventions: Other: Resistance training for knee extensors

• Registration Number: NCT05731037
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-16
• Study Start: 2023-03-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-02-10
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Sports active men and women.
• Age (18-60) years old.
• BMI (18.5-30)
• Understand and read Danish
• Uni- or bilateral patellar tendinopathy
• Symptom onset >90 days ago

Exclusion Criteria

• Patellar tendinopathy longer than 24 months
• Smoking
• Previous surgery in the knee on the ipsilateral side.
• Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months.
• Any confounding diagnosis to the knee joint
• Known arthritis
• Known diabetes
• Inability to follow rehabilitation or complete follow-ups
• Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three month
• Have a work were it is not feasible to avoid pain provoking tasks

Extra criteria sub-study one

Inclusion criteria:

• Five patients from the main study, rating "improved" and "not improved" respectively, will be invited to participate in sub-study one.

Exclusion criteria:

• Claustrophobia
• Pregnancy
• Breastfeeding

Extra criteria sub-study two:

Inclusion criteria:

• Patients from the main study, that rate themselves 'not improved' in symptoms after 12 week.
• Patients who have not achieved Patient Acceptable Symptom State (PASS) after week 20, 24, 28, 32, 36 and 40, will be invited to participate in sub- study two.

Exclusion criteria:

• Pregnancy
• Breastfeeding
• Previously had an allergic reaction for steroid (Depomedrol).
• Previously had an allergic reaction for local anesthesia treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short restitution group (SR)	Resistance training for knee extensors	Resistance training for knee extensors three training session per week.
Extended restitution group (ER)	Resistance training for knee extensors	Resistance training for knee extensors on training session per week (greater restitution from loading).

Primary Outcome Measures

Name	Time	Method
Patient perception VISA-P	Change from baseline at week 12	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.

Secondary Outcome Measures

Name	Time	Method
Ultrasonography - tendon microvascularisation	Change from baseline at week 12 and 52.	B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation.
Self-reported pain (NRS) - Preferred sport	Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	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.
Self-reported pain (NRS) - Daily activities	Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	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.
Care-seeking behavior	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	Registration of any additive care-seeking behavior from last follow-up measured with self-reported questionnaire.
Sports types	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	Typer of sports performed.
Self-reported pain (NRS) - Rest	Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	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.
Self-reported improvement (GROC)	Change from baseline at week 12, 16 and 52.	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'.
Sports participation	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	Number of sports participation hours per week (training and competition).
Counter movement Jump height	Change from baseline at week 12 and 52.	Jump height during Counter movement Jump test will be used to assess patellar tendinopathy caused functional deficits.
Patient perception VISA-P truncated	Change from baseline at week 12, 16 and 52	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.
Treatment received	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	Registration of any additive treatment received from last follow-up measured with self-reported questionnaire.
The single-leg decline squat (SLDS) will be used to assess pain during function	Change from baseline at week 12 and 52.	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.
Muscle strength	Change from baseline at week 12 and 52.	Maximal muscle strength is obtained during standardized maximal voluntary contractions.
Ultrasonography - tendon neovascularization	Change from baseline at week 12 and 52.	Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization.
Sports intensity	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.	Intensity of sport performed registred in a self-reported questianaire and categorized as; light, moderate or vigorous.
Self-reported satisfaction (PASS)	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52	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'
Ultrasonography - tendon thickness	Change from baseline at week 12 and 52.	Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Patient perception VISA-P secondary	Change from baseline at week 16 and 52	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.

Trial Locations

Locations (1)

Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg Hospital; 🇩🇰 Copenhagen, NV, Denmark