Achilles Tendinopathy Treated With Training and Injections

NCT02580630 | Completed Phase 4 DMC

• 1 other identifier: H-15006579
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare in a randomized double blinded controlled trial the effect of heavy slow resistance exercises combined with ultrasound guided injections with local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.

Conditions

Achilles Tendinopathy

Keywords

Strength training, injection, glucocorticoid

Outcome Measures

Primary Outcomes (1)

• VISA-A score

  VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.

  6 month

Secondary Outcomes (3)

• VISA-A score

  3, 12, 24 months

• Global rating scale for recovery

  1, 2, 3, 6, 12, 24 months

• Ultrasound scanning

  3, 6, 12, 24 months

Other Outcomes (1)

• patient pain and exercise diary

  week 1,2,3,4,5,6,7,8,9,10,11,12,13

Study Arms (2)

Training and glucocorticosteroid

ACTIVE COMPARATOR

Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month. All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity. Ultrasound guided injection with glucocorticosteroid: 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).

Behavioral: Reduction in running and jumping; Other: Training; Drug: Ultrasound guided injection with Glucocorticosteroid

Training and local anesthetic

ACTIVE COMPARATOR

Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month. All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity. Ultrasound guided injection with local anaestethic: 1ml Lidocain 5 mg/ml and 1 ml intralipid (for blinding) in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).

Behavioral: Reduction in running and jumping; Other: Training; Drug: Ultrasound guided injection with local anaestethic

Interventions

Reduction in running and jumping BEHAVIORAL

Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.

Also known as: Impact reduction

Training and glucocorticosteroid; Training and local anesthetic

Training OTHER

Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then week 3, 6, 10. The patient will register all training on a diary and on an App.

Also known as: Heavy slow resistance training

Training and glucocorticosteroid; Training and local anesthetic

Ultrasound guided injection with Glucocorticosteroid DRUG

Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml. Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).

Also known as: Glucocorticosteroid

Training and glucocorticosteroid

Ultrasound guided injection with local anaestethic DRUG

Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml of intralipid (for blinding). Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).

Also known as: local anaestethic

Training and local anesthetic

Eligibility Criteria

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

You may qualify if:

• Midsubstance pain in the achilles tendon
• Symptoms for at least 3 months
• Ultrasound scanning at the first visit shows thickness of the achilles tendon above 7 mm or 20% thicker than the contralateral.
• Patient can read and understand danish

You may not qualify if:

• Earlier operations in the foot and leg, that is judged to complicate training
• known arthritis.
• known diabetes
• Leg ulcerations or infections in the foot.
• Judged unable to comply with the training protocol.
• Daily use of pain killers
• Glucocorticosteroid injection to the diseased achilles tendon within the last 6 months.
• Earlier allergic reactions to glucocorticosteroid or local anesthetic.
• Pregnancy or planning to become pregnant
• BMI above 30.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• The Danish Rheumatism Association: collaborator

Study Sites (1)

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

København NV, dk-2400, Denmark

Location

Related Publications (1)

• Johannsen F, Olesen JL, Ohlenschlager TF, Lundgaard-Nielsen M, Cullum CK, Jakobsen AS, Rathleff MS, Magnusson PS, Kjaer M. Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2219661. doi: 10.1001/jamanetworkopen.2022.19661.

  PMID: 35816306 DERIVED

MeSH Terms

Interventions

Running

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Finn E Johannsen, MD

  Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Jens L Olesen, MD, PhD

  Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Michael S Rathleff, PT, PhD

  Research Unit for General Practice in Aalborg, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: chief physician, MD, specialist in Rheumatology

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: April 1, 2016
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

DK (1)