Achilles TendinopathyPhase 4NCT02580630
Achilles Tendinopathy Treated With Training and Injections
A Phase 4 study testing Reduction in running and jumping, Training and Ultrasound guided injection with Glucocorticosteroid in people with Achilles Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Reduction in running and jumping, Training and Ultrasound guided injection with Glucocorticosteroid
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to 20 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
København NV, dk-2400
About this study
Official title: 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.
Read the 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.
- Conditions
- Achilles Tendinopathy
- Being tested
- Reduction in running and jumping, Training, Ultrasound guided injection with Glucocorticosteroid, Ultrasound guided injection with local anaestethic
- Keywords
- Strength training, injection, glucocorticoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction in running and jumpingBehavioural
Also called Impact reduction
Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.
TrainingOther
Also called Heavy slow resistance 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.
Ultrasound guided injection with GlucocorticosteroidDrug
Also called 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).
Ultrasound guided injection with local anaestethicDrug
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Reduction in running and jumping; Other: Training; Drug: Ultrasound guided injection with local anaestethic |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A score
VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.
Measured: 6 month
Secondary outcomes (3)
VISA-A score
Measured: 3, 12, 24 months
Global rating scale for recovery
11 point box scale
Measured: 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)
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startApr 2016
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Responsible party
- Principal investigator, Finn Elkjær Johannsen, Bispebjerg Hospital
- Investigators
- Finn E Johannsen, MD, Principal investigator, Institute of Sports Medicine Copenhagen, University of Copenhagen, DenmarkJens L Olesen, MD, PhD, Principal investigator, Institute of Sports Medicine Copenhagen, University of Copenhagen, DenmarkMichael S Rathleff, PT, PhD, Study chair, Research Unit for General Practice in Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580630
- Sponsor's protocol ID
- H-15006579
- Status last verified
- Jul 2021
- First submitted
- 19 Oct 2015
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 35816306
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Tendinopathy Treated With Heavy Slow Resistance Training Supplemented With Injection of Glucocorticosteroid or Local Anaesthetic.
- ClinicalTrials.gov ID
- NCT02580630
- Acronym / sponsor ID
- H-15006579
- Conditions
- Achilles Tendinopathy
- Keywords
- Strength training, injection, glucocorticoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Study start
- Apr 2016
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training and glucocorticosteroid | Active comparator | Behavioral: Reduction in running and jumping, Other: Training, Drug: Ultrasound guided injection with GlucocorticosteroidPatients 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). |
| Training and local anesthetic | Active comparator | Behavioral: Reduction in running and jumping, Other: Training, Drug: Ultrasound guided injection with local anaestethicPatients 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction in running and jumpingAlso: Impact reductionAdvocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity. | Behavioural | Training and glucocorticosteroid, Training and local anesthetic |
| TrainingAlso: Heavy slow resistance trainingPatients 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 | Training and glucocorticosteroid, Training and local anesthetic |
| Ultrasound guided injection with GlucocorticosteroidAlso: GlucocorticosteroidUltrasound 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). | Drug | Training and glucocorticosteroid |
| Ultrasound guided injection with local anaestethicAlso: local anaestethicUltrasound 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). | Drug | Training and local anesthetic |
Primary outcome
VISA-A score
Time frame: 6 month
VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.
3 secondary outcomes
VISA-A score
Time frame: 3, 12, 24 months
Global rating scale for recovery
Time frame: 1, 2, 3, 6, 12, 24 months
Ultrasound scanning
Time frame: 3, 6, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 35816306Johannsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn E Johannsen, MD principal investigator
Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark
Jens L Olesen, MD, PhD principal investigator
Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark
Michael S Rathleff, PT, PhD study chair
Research Unit for General Practice in Aalborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reduction in running and jumping, Training and Ultrasound guided injection with Glucocorticosteroid in people with Achilles Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISA-A score (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.