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Achilles Tendinopathy Treated With Training and Injections

Primary Purpose

Achilles Tendinopathy

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Reduction in running and jumping
Training
Ultrasound guided injection with Glucocorticosteroid
Ultrasound guided injection with local anaestethic
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Strength training, injection, glucocorticoid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Training and glucocorticosteroid

Training and local anesthetic

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VISA-A score
Global rating scale for recovery
11 point box scale
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)

Full Information

First Posted
October 19, 2015
Last Updated
July 21, 2021
Sponsor
Bispebjerg Hospital
Collaborators
The Danish Rheumatism Association
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1. Study Identification

Unique Protocol Identification Number
NCT02580630
Brief Title
Achilles Tendinopathy Treated With Training and Injections
Official Title
Achilles Tendinopathy Treated With Heavy Slow Resistance Training Supplemented With Injection of Glucocorticosteroid or Local Anaesthetic.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
The Danish Rheumatism Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
Strength training, injection, glucocorticoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training and glucocorticosteroid
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Training and local anesthetic
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Reduction in running and jumping
Other Intervention Name(s)
Impact reduction
Intervention Description
Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
Heavy slow resistance training
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided injection with Glucocorticosteroid
Other Intervention Name(s)
Glucocorticosteroid
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided injection with local anaestethic
Other Intervention Name(s)
local anaestethic
Intervention Description
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).
Primary Outcome Measure Information:
Title
VISA-A score
Description
VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
VISA-A score
Time Frame
3, 12, 24 months
Title
Global rating scale for recovery
Description
11 point box scale
Time Frame
1, 2, 3, 6, 12, 24 months
Title
Ultrasound scanning
Description
measurement of the thickness of the achilles tendon and evaluating the tendon structure and flow on a 4 point scale (Newman grading scale)
Time Frame
3, 6, 12, 24 months
Other Pre-specified Outcome Measures:
Title
patient pain and exercise diary
Description
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.
Time Frame
week 1,2,3,4,5,6,7,8,9,10,11,12,13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn E Johannsen, MD
Organizational Affiliation
Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens L Olesen, MD, PhD
Organizational Affiliation
Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael S Rathleff, PT, PhD
Organizational Affiliation
Research Unit for General Practice in Aalborg, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
City
København NV
ZIP/Postal Code
dk-2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35816306
Citation
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.
Results Reference
derived

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Achilles Tendinopathy Treated With Training and Injections

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