Influence of Restitution Time in Treatment of Patellar Tendinopathy

Patellar Tendinopathy Clinical Trial

— TEREX  

Official title:

Patellar Tendinopathy - The Role of Restitution Time in Exercise- Based Treatment: A Randomized Controlled Trial (the TEREX Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731037
• Other study ID #: The TEREX trial
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: Bispebjerg Hospital
• Contact: Anne-Sofie Agergaard, PhD
• Phone: 004521156240
• Email: anne-sofie.agergaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 1, 2027
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jumper's Knee
• Patellar Tendinopathy
• Tendinopathy

Intervention

Other:
• Resistance training for knee extensors
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).

Locations

Country	Name	City	State
Denmark	Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg Hospital	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain structure mapping.	It will be testet If it is feasible to map brain structure changes in patient with chronic patellar tendinopathy using MRI BOLD imaging technique. The outcome will only be used for participants included in sub-study one.	At 12 weeks
Other	Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain function mapping.	It will be testet If it is feasible to map brain function changes in patient with chronic patellar tendinopathy using MRI BOLD imaging technique. The outcome will only be used for participants included in sub-study one.	At 12 weeks
Other	Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain metabolism mapping.	It will be testet If it is feasible to map brain metabolism changes in patient with chronic patellar tendinopathy using MRI BOLD imaging technique. The outcome will only be used for participants included in sub-study one.	At 12 weeks
Other	Correlation between patient self-reported satisfaction and brain structure changes.	Patient self-reported satisfaction will be assessed by Patient Acceptable Symptom State (PASS) and brain structure by Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique. The outcome will only be used for participants included in sub-study one.	At 12 weeks
Other	Correlation between patient self-reported satisfaction and brain function changes.	Patient self-reported satisfaction will be assessed by Patient Acceptable Symptom State (PASS) and brain function by Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique. The outcome will only be used for participants included in sub-study one.	At 12 weeks
Other	Correlation between patient self-reported satisfaction and brain metabolism changes.	Patient self-reported satisfaction will be assessed by Patient Acceptable Symptom State (PASS) and brain metabolism by Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique. The outcome will only be used for participants included in sub-study one.	At 12 weeks
Other	Number of corticosteroid injections received	Number of injections received from week 12-52 for patients participating in sub-study two.	week 12 to 52
Other	Tendon thickness after injection.	Grey scale ultrasonography will be used for evaluation of patellar tendon thickness. Only for patients participating in sub-study two.	Change from 1. injection and at week 4 and 8 after the injection.
Other	Tendon neovascularization after injection.	Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization. Only for patients participating in sub-study two.	Change from 1. injection and at week 4 and 8 after the injection.
Other	Tendon microvascular blood flow after injection.	B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation. Only for patients participating in sub-study two.	Change from 1. injection and at week 4 and 8 after the injection.
Other	Self-reported satisfaction after injection.	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'Symptom State (PASS) scale.	Change from 1. injection and at week 4 and 8 after the injection.
Other	Registration of pain rating on numeric rating scale (NRS) during injection.	Pain rating will be evaluated on an 11 point numeric rating scale (NRS) during injection, with 10 being the worst imaginable pain and 0 denoting no pain. Only for patients participating in sub-study two.	Week 12 to 52
Primary	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.	Change from baseline at week 12
Secondary	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.	Change from baseline at week 16 and 52
Secondary	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.	Change from baseline at week 12, 16 and 52
Secondary	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.	Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	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.	Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	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.	Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	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'.	Change from baseline at week 12, 16 and 52.
Secondary	Sports participation	Number of sports participation hours per week (training and competition).	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	Sports types	Typer of sports performed.	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	Sports intensity	Intensity of sport performed registred in a self-reported questianaire and categorized as; light, moderate or vigorous.	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	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'	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Secondary	Treatment received	Registration of any additive treatment received from last follow-up measured with self-reported questionnaire.	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	Care-seeking behavior	Registration of any additive care-seeking behavior from last follow-up measured with self-reported questionnaire.	Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Secondary	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.	Change from baseline at week 12 and 52.
Secondary	Muscle strength	Maximal muscle strength is obtained during standardized maximal voluntary contractions.	Change from baseline at week 12 and 52.
Secondary	Ultrasonography - tendon thickness	Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.	Change from baseline at week 12 and 52.
Secondary	Ultrasonography - tendon neovascularization	Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization.	Change from baseline at week 12 and 52.
Secondary	Ultrasonography - tendon microvascularisation	B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation.	Change from baseline at week 12 and 52.
Secondary	Counter movement Jump height	Jump height during Counter movement Jump test will be used to assess patellar tendinopathy caused functional deficits.	Change from baseline at week 12 and 52.