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Completed

NCT Number: NCT02580630

Achilles Tendinopathy Treated With Training and Injections

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

København NV, dk-2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Impact reduction

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.

Other names: Heavy slow resistance training

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).

Other names: 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).

Other names: local anaestethic

Primary outcomes

  1. VISA-A score

    Time frame: 6 month

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

Secondary outcomes

  1. VISA-A score

    Time frame: 3, 12, 24 months

  2. Global rating scale for recovery

    Time frame: 1, 2, 3, 6, 12, 24 months

    11 point box scale

  3. Ultrasound scanning

    Time frame: 3, 6, 12, 24 months

    measurement of the thickness of the achilles tendon and evaluating the tendon structure and flow on a 4 point scale (Newman grading scale)

Other outcomes

  1. patient pain and exercise diary

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

    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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • The Danish Rheumatism Association

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2015
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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