Resistance Training and Injection Treatment for Achilles Enthesopathy

NCT04232358 | Active Not Recruiting

• 1 other identifier: H-19041374
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies. The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection. 50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.

Conditions

Achilles Entesopathy

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

  6 months

Secondary Outcomes (5)

• Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)

  3, 9 and 12 months

• Evaluation of treatment effect measured on a Likert scale.

  1, 2, 3, 6, 9 and 12 months

• Ultrasonographic measurement of achilles tendon thickness

  1, 2, 3, 6, 9 and 12 months

• Patient self reported activity level in percentage of the pre-injury activity level

  3, 6 and 12 months

• Ultrasonographic measurement of achilles tendon doppler activity

  1, 2, 3, 6, 9 and 12 months

Study Arms (2)

Corticosteroid injections + resistance training

EXPERIMENTAL

Corticosteroid injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months

Drug: Corticosteroid injection

Local anesthesia injections + resistance training

PLACEBO COMPARATOR

Local anesthesia injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months

Drug: Local anesthesia injections

Interventions

Corticosteroid injection DRUG

Corticosteroid injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.

Corticosteroid injections + resistance training

Local anesthesia injections DRUG

Local anesthesia injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.

Local anesthesia injections + 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 insertion/heel for at least 3 months
• Achilles entesopathy verified by ultrasound
• Between 18 and 65 years of age

You may not qualify if:

• 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 entesopathy within the last 6 months

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

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

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 18, 2020
• Study Start: May 4, 2021
• Primary Completion: November 4, 2024
• Study Completion: May 4, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)