Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy

Achilles Tendinopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04210999
• Other study ID #: H-19040270
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: December 2022
• Source: Bispebjerg Hospital
• Contact: Simon Doessing, MD. PhD
• Phone: +4538635042
• Email: simon.doessing.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Other:
• Homebased resistance training
Resistance training at home instructed via a smart phone training app
• Supervised heavy slow resistance training
Heavy slow resistance training in the gym instructed by a physiotherapist

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.