search
Back to results

Influence of Restitution Time in Treatment of Patellar Tendinopathy (TEREX)

Primary Purpose

Patellar Tendinopathy, Jumper's Knee

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training for knee extensors
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sports active men and women. Age (18-60) years old. BMI (18.5-28) 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.

Sites / Locations

  • Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Short restitution group (SR)

Extended restitution group (ER)

Arm Description

Resistance training for knee extensors three training session per week.

Resistance training for knee extensors on training session per week (greater restitution from loading).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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'.
Sports participation
Number of sports participation hours per week (training and competition).
Sports types
Typer of sports performed.
Sports intensity
Intensity of sport performed registred in a self-reported questianaire and categorized as; light, moderate or vigorous.
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'
Treatment received
Registration of any additive treatment received from last follow-up measured with self-reported questionnaire.
Care-seeking behavior
Registration of any additive care-seeking behavior from last follow-up measured with self-reported questionnaire.
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.
Muscle strength
Maximal muscle strength is obtained during standardized maximal voluntary contractions.
Ultrasonography - tendon thickness
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Ultrasonography - tendon neovascularization
Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization.
Ultrasonography - tendon microvascularisation
B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation.
Counter movement Jump height
Jump height during Counter movement Jump test will be used to assess patellar tendinopathy caused functional deficits.

Full Information

First Posted
January 27, 2023
Last Updated
August 23, 2023
Sponsor
Bispebjerg Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05731037
Brief Title
Influence of Restitution Time in Treatment of Patellar Tendinopathy
Acronym
TEREX
Official Title
Patellar Tendinopathy - The Role of Restitution Time in Exercise- Based Treatment: A Randomized Controlled Trial (the TEREX Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
February 10, 2025 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy, Jumper's Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short restitution group (SR)
Arm Type
Active Comparator
Arm Description
Resistance training for knee extensors three training session per week.
Arm Title
Extended restitution group (ER)
Arm Type
Experimental
Arm Description
Resistance training for knee extensors on training session per week (greater restitution from loading).
Intervention Type
Other
Intervention Name(s)
Resistance training for knee extensors
Intervention Description
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).
Primary Outcome Measure Information:
Title
Patient perception VISA-P
Description
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
Secondary Outcome Measure Information:
Title
Patient perception VISA-P secondary
Description
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
Title
Patient perception VISA-P truncated
Description
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
Title
Self-reported pain (NRS) - Preferred sport
Description
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.
Title
Self-reported pain (NRS) - Rest
Description
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.
Title
Self-reported pain (NRS) - Daily activities
Description
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.
Title
Self-reported improvement (GROC)
Description
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.
Title
Sports participation
Description
Number of sports participation hours per week (training and competition).
Time Frame
Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Title
Sports types
Description
Typer of sports performed.
Time Frame
Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Title
Sports intensity
Description
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.
Title
Self-reported satisfaction (PASS)
Description
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
Title
Treatment received
Description
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.
Title
Care-seeking behavior
Description
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.
Title
The single-leg decline squat (SLDS) will be used to assess pain during function
Description
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.
Title
Muscle strength
Description
Maximal muscle strength is obtained during standardized maximal voluntary contractions.
Time Frame
Change from baseline at week 12 and 52.
Title
Ultrasonography - tendon thickness
Description
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Time Frame
Change from baseline at week 12 and 52.
Title
Ultrasonography - tendon neovascularization
Description
Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization.
Time Frame
Change from baseline at week 12 and 52.
Title
Ultrasonography - tendon microvascularisation
Description
B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation.
Time Frame
Change from baseline at week 12 and 52.
Title
Counter movement Jump height
Description
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.
Other Pre-specified Outcome Measures:
Title
Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain structure mapping.
Description
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.
Time Frame
At 12 weeks
Title
Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain function mapping.
Description
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.
Time Frame
At 12 weeks
Title
Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain metabolism mapping.
Description
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.
Time Frame
At 12 weeks
Title
Correlation between patient self-reported satisfaction and brain structure changes.
Description
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.
Time Frame
At 12 weeks
Title
Correlation between patient self-reported satisfaction and brain function changes.
Description
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.
Time Frame
At 12 weeks
Title
Correlation between patient self-reported satisfaction and brain metabolism changes.
Description
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.
Time Frame
At 12 weeks
Title
Number of corticosteroid injections received
Description
Number of injections received from week 12-52 for patients participating in sub-study two.
Time Frame
week 12 to 52
Title
Tendon thickness after injection.
Description
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness. Only for patients participating in sub-study two.
Time Frame
Change from 1. injection and at week 4 and 8 after the injection.
Title
Tendon neovascularization after injection.
Description
Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization. Only for patients participating in sub-study two.
Time Frame
Change from 1. injection and at week 4 and 8 after the injection.
Title
Tendon microvascular blood flow after injection.
Description
B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation. Only for patients participating in sub-study two.
Time Frame
Change from 1. injection and at week 4 and 8 after the injection.
Title
Self-reported satisfaction after injection.
Description
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.
Time Frame
Change from 1. injection and at week 4 and 8 after the injection.
Title
Registration of pain rating on numeric rating scale (NRS) during injection.
Description
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.
Time Frame
Week 12 to 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sports active men and women. Age (18-60) years old. BMI (18.5-28) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sofie Agergaard, PhD
Phone
004521156240
Email
anne-sofie.agergaard@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Magnusson, Professor
Phone
0046708826683
Email
p.magnusson@sund.ku.dk
Facility Information:
Facility Name
Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg Hospital
City
Copenhagen
State/Province
NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sofie Agergaard, PhD
Phone
004521156240
Email
anne-sofie.agergaard@regionh.dk
First Name & Middle Initial & Last Name & Degree
Peter Magnusson, Professor
Phone
0046708826683
Email
p.magnusson@sund.ku.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of Restitution Time in Treatment of Patellar Tendinopathy

We'll reach out to this number within 24 hrs