Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy

NCT04210999 | Active Not Recruiting

• 1 other identifier: H-19040270
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of treatment effect measured on an 11-point Likert scale.

  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).

  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.

  After 3 months in study 1. After 3 months in study 2.

• Ultrasonographic measurement of achilles tendon thickness and doppler activity.

  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.

  After 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.

Study Arms (2)

Homebased resistance training

EXPERIMENTAL

Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months

Other: Homebased resistance training

Supervised resistance training

ACTIVE COMPARATOR

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

Interventions

Homebased resistance training OTHER

Resistance training at home instructed via a smart phone training app

Homebased resistance training

Supervised heavy slow resistance training OTHER

Heavy slow resistance training in the gym instructed by a physiotherapist

Supervised resistance training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Study Officials

• Michael Kjaer, MD. PhD

  University of Copenhagen and Bispebjerg Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Surgeon

Model Details: RCT

Study Record Dates

• First Submitted: December 22, 2019
• First Posted: December 26, 2019
• Study Start: April 5, 2022
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

DK (1)