Achilles Tendinopathy Treated With Training and Injections

Achilles Tendinopathy Treated With Heavy Slow Resistance Training Supplemented With Injection of Glucocorticosteroid or Local Anaesthetic.

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Behavioral: Reduction in running and jumping; Other: Training; Drug: Ultrasound guided injection with Glucocorticosteroid; Drug: Ultrasound guided injection with local anaestethic

Detailed Description

Achilles tendinopathy is a common and often longlasting condition especially in a sports population. The highest incidence is seen in sports involving running and jumping.

As the primary treatment eccentric exercises is recommended and 60-90% will benefit by that. Other studies have shown equal effect of stretching exercises. In a new study heavy slow resistance exercises has proven effective in achilles tendinopathy and the best treatment in lig.patellae tendinopathy.

Injection with glucocorticosteroid is often used in the daily clinic, though inflammation is rarely found. Fredberg 2004 found a good short term effect of glucocorticosteroid injection in an RCT, but no effect in the long term, which the investigators explained by an aggressive rehabilitation with running after a few days. Even though 60-90% will benefit from exercises in efficacy studies, a recent pragmatic effectiveness study by Weetke 2015 found that only 26% did benefit from training alone, but if supplemented by need with 1-3 injections of glucocorticosteroid 76% achieved excellent or good result.

To our knowledge no randomized clinical trials have investigated the combined effect of training and injections. The hypothesis of this study is, that training and slowly progressive rehabilitation combined with glucocorticosteroid injections will have better effect than the same training and rehabilitation combined with injections of local anesthetic.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • København NV, Denmark, dk-2400
    • Institute of Sports Medicine copenhagen, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Training and glucocorticosteroid; 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; Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.; Other Names: Impact reduction; Other: Training; 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.; Other Names: Heavy slow resistance training; Drug: Ultrasound guided injection with Glucocorticosteroid; 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).; Other Names: Glucocorticosteroid
Active Comparator: Training and local anesthetic; 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; Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.; Other Names: Impact reduction; Other: Training; 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.; Other Names: Heavy slow resistance training; Drug: Ultrasound guided injection with local anaestethic; 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).; Other Names: local anaestethic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VISA-A score	VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VISA-A score		3, 12, 24 months
Global rating scale for recovery	11 point box scale	1, 2, 3, 6, 12, 24 months
Ultrasound scanning	measurement of the thickness of the achilles tendon and evaluating the tendon structure and flow on a 4 point scale (Newman grading scale)	3, 6, 12, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient pain and exercise diary	100 mm VAS score for morning pain (average in the week), 100 mm VAS score for pain during training (average in the week). Compliance to the treatment, Side effects to injections is described.	week 1,2,3,4,5,6,7,8,9,10,11,12,13

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: The Danish Rheumatism Association
• Investigators: Principal Investigator: 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; Study Chair: Michael S Rathleff, PT, PhD, Research unit for General Practice in Aalborg, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Strength training, injection, glucocorticoid
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: H-15006579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided