Clinical trial NCT02580630: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Achilles Tendinopathy
Keywords: Strength training, injection, glucocorticoid
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
First posted: 2015-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: VISA-A score
timeFrame: 6 month
Secondary outcomes:
measure: VISA-A score
timeFrame: 3, 12, 24 months
measure: Global rating scale for recovery
timeFrame: 1, 2, 3, 6, 12, 24 months
measure: Ultrasound scanning
timeFrame: 3, 6, 12, 24 months
Other outcomes:
measure: patient pain and exercise diary
timeFrame: week 1,2,3,4,5,6,7,8,9,10,11,12,13
Locations:
city: København NV
country: Denmark
facility: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark
name: Finn E Johannsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark
name: Jens L Olesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit for General Practice in Aalborg, Denmark
name: Michael S Rathleff, PT, PhD
role: STUDY_CHAIR
References:
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.