ClinicalTrials.gov
ClinicalTrials.gov Menu

Achilles Tendinopathy Treated With Training and Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02580630
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
The Danish Rheumatism Association
Information provided by (Responsible Party):
Finn Elkjær Johannsen, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Behavioral: Reduction in running and jumping Other: Training Drug: Ultrasound guided injection with Glucocorticosteroid Drug: Ultrasound guided injection with local anaestethic Phase 4

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Achilles Tendinopathy Treated With Heavy Slow Resistance Training Supplemented With Injection of Glucocorticosteroid or Local Anaesthetic.
Study Start Date : April 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: local anaestethic




Primary Outcome Measures :
  1. VISA-A score [ Time Frame: 6 month ]
    VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580630


Contacts
Contact: Finn E Johannsen, MD f.e.johannsen@dadlnet.dk
Contact: Jens L Olesen, MD, PhD jlo@rn.dk

Locations
Denmark
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Recruiting
København NV, Denmark, dk-2400
Contact: Finn Johannsen, MD    0045 31671057    f.e.johannsen@dadlnet.dk   
Contact: Jens Olesen, MD       jlo@rn.dk   
Sponsors and Collaborators
Bispebjerg Hospital
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

Responsible Party: Finn Elkjær Johannsen, chief physician, MD, specialist in Rheumatology, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02580630     History of Changes
Other Study ID Numbers: H-15006579
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Finn Elkjær Johannsen, Bispebjerg Hospital:
Strength training, injection, glucocorticoid

Additional relevant MeSH terms:
Muscular Diseases
Tendon Injuries
Tendinopathy
Musculoskeletal Diseases
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Methylprednisolone
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents