Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy

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

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:

1. Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy
2. HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1
3. 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

Study Overview

• Status: Recruiting
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Other: Homebased resistance training; Other: Supervised heavy slow resistance training

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)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Doessing, MD. PhD; Phone Number: +4538635042; Email: simon.doessing.01@regionh.dk
• Study Contact Backup: Name: Finn Johannsen, MD.; Phone Number: +4538635042; Email: f.e.johannsen@dadlnet.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Recruiting
    • Bispebjerg Hospital
    • Contact: Simon Doessing, M.D. PhD; Phone Number: +4535316089; Email: simondoessing@gmail.com
    • Contact: Michael Kjaer, M.D. PhD; Phone Number: +4535316089; Email: Michael.Kjaer@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Homebased resistance training; Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months	Other: Homebased resistance training; Resistance training at home instructed via a smart phone training app
Active Comparator: Supervised resistance training; Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months	Other: Supervised heavy slow resistance training; Heavy slow resistance training in the gym instructed by a physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 3 and 6 months in study 1. After 6 months in study 2. After 6 and 12 months in study 3.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 1, 2, 3, 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
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.	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.
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.	After 3 months in study 1. After 3 months in study 2.
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.	After 0, 1, 2, 3, 6 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
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.	After 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Study Director: Michael Kjaer, MD. PhD, University of Copenhagen and Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: H-19040270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No