Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy
Primary Purpose
Achilles Tendinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Homebased resistance training
Supervised heavy slow resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy
Eligibility Criteria
Inclusion Criteria:
- Pain from the achilles tendon either unilateral or bilateral for at least 3 months
- Achilles tendinopathy in the tendon midtsubstance verified by ultrasound
- Between 18 and 65 years of age
- For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
- For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm
Exclusion Criteria:
- Prior surgery in the leg with the exception of knee artroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles tendinopati within the last 6 months
Sites / Locations
- Bispebjerg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Homebased resistance training
Supervised resistance training
Arm Description
Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months
Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Outcomes
Primary Outcome Measures
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
Secondary Outcome Measures
Evaluation of treatment effect measured on an 11-point Likert scale.
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is cured and -5 is much worsened, 0 is the status when entering the study.
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
Evaluation of the training experience measured on a Likert scale.
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is very inspiring/motivating, -5 is very uninspiring/boring, 0 representing the status when entering the study.
Ultrasonographic measurement of achilles tendon thickness and doppler activity.
Ultrasonographic measurement of achilles tendon thickness and doppler activity is measured relative to the baseline values.
Patient self reported activity level in percentage of the pre-injury activity level.
Self reported activity level in percentage of the pre-injury activity level is reported.
Full Information
NCT ID
NCT04210999
First Posted
December 22, 2019
Last Updated
December 12, 2022
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04210999
Brief Title
Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy
Official Title
Is Supervised or Homebased Resistance Training the Best Treatment for Chronic Achilles Tendinopathy? And When Needed is Supplement Treatment With Either Corticosteroid or High Volume Injection the Best Choice
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2026 (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
No
5. Study Description
Brief Summary
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals.
The primary purpose of the study is to compare treatment with supervised or homebased resistance training. The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment.
The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment.
It is hypothesized that:
Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy
HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1
Surgery improves symptoms in patients not responding to treatment 1 and treatment 2
Study 1: 90 patients between 18 and 65 years of age with achilles tendinopathy for at least 3 months are randomly assigned to either A. Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months B. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Outcomes are change in patient reported outcome (VISA-A) from baseline to 3 and 6 months, ultrasound measured thickness and dopler activity of the achilles tendon, self reported activity level in percentage of the pre injury activity level.
After the 3-month training intervention, and for the following 9 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the second part of the study.
Study 2: Patients from study 1 which not are satisfied with the outcome are randomly assigned to either
A. Same training intervention continued + High Volume Injection (HVI) B. Same training intervention continued + corticosteroid injection
After the 4-month and for the following 8 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the third part of the study.
Study 3: Patients from study 2 which not are satisfied with the outcome are operated
Detailed Description
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals. Treatment options typically include rest from high load weight bearing activities, resistance training, injections with corticosteroid (CS) or High Volume Injection (HVI) and surgery.
The primary purpose of the study is to compare treatment with supervised or homebased resistance training.
The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment.
The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment.
It is hypothesized that:
4. Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy (RCT, non-inferiority design).
5. HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1. (RCT, superiority design).
6. Surgery improves symptoms in patients not responding to treatment 1. and treatment 2. (prospective cohort).
Study 1: 90 patients with achilles tendinopathy are randomly assigned to either
C. Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months D. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Inclusion criteria
Pain from the achilles tendon either unilateral or bilateral for at least 3 months
Achilles tendinopathy in the tendon midsubstance verified by ultrasound
Between 18 and 65 years of age
For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm Exclusion criteria
Prior surgery in the leg with the exception of knee arthroscopy
Known medial conditions including diabetes or rheumatologic diseases
Taking pain medication regularly
Injection therapy for treatment of achilles tendinopathy within the last 6 months
Patients are stratified based on the severity of symptoms (below or above 50 on VISA-A) and duration of symptoms (shorter or longer than 1 year)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Homebased resistance training
Arm Type
Experimental
Arm Description
Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months
Arm Title
Supervised resistance training
Arm Type
Active Comparator
Arm Description
Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Intervention Type
Other
Intervention Name(s)
Homebased resistance training
Intervention Description
Resistance training at home instructed via a smart phone training app
Intervention Type
Other
Intervention Name(s)
Supervised heavy slow resistance training
Intervention Description
Heavy slow resistance training in the gym instructed by a physiotherapist
Primary Outcome Measure Information:
Title
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
Description
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
Time Frame
After 3 and 6 months in study 1. After 6 months in study 2. After 6 and 12 months in study 3.
Secondary Outcome Measure Information:
Title
Evaluation of treatment effect measured on an 11-point Likert scale.
Description
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is cured and -5 is much worsened, 0 is the status when entering the study.
Time Frame
After 1, 2, 3, 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Title
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
Description
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
Time Frame
After 1, 2, 9 and 12 months in study 1. After 1, 3, 6, 9 and 12 months in study 2. After 3 months in study 3.
Title
Evaluation of the training experience measured on a Likert scale.
Description
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is very inspiring/motivating, -5 is very uninspiring/boring, 0 representing the status when entering the study.
Time Frame
After 3 months in study 1. After 3 months in study 2.
Title
Ultrasonographic measurement of achilles tendon thickness and doppler activity.
Description
Ultrasonographic measurement of achilles tendon thickness and doppler activity is measured relative to the baseline values.
Time Frame
After 0, 1, 2, 3, 6 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Title
Patient self reported activity level in percentage of the pre-injury activity level.
Description
Self reported activity level in percentage of the pre-injury activity level is reported.
Time Frame
After 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain from the achilles tendon either unilateral or bilateral for at least 3 months
Achilles tendinopathy in the tendon midtsubstance verified by ultrasound
Between 18 and 65 years of age
For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm
Exclusion Criteria:
Prior surgery in the leg with the exception of knee artroscopy
Known medial conditions including diabetes or rheumatologic diseases
Taking pain medication regularly
Injection therapy for treatment of achilles tendinopati within the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Doessing, MD. PhD
Phone
+4538635042
Email
simon.doessing.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Finn Johannsen, MD.
Phone
+4538635042
Email
f.e.johannsen@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kjaer, MD. PhD
Organizational Affiliation
University of Copenhagen and Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Doessing, M.D. PhD
Phone
+4535316089
Email
simondoessing@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael Kjaer, M.D. PhD
Phone
+4535316089
Email
Michael.Kjaer@regionh.dk
12. IPD Sharing Statement
Learn more about this trial
Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy
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