Achilles Tendinopathy Treated With Training and Injections

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580630
• Other study ID #: H-15006579
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: December 20, 2020

Study information

• Verified date: July 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

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:
• 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.

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).
• 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).

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen, Bispebjerg Hospital	København NV

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient pain and exercise diary	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.	week 1,2,3,4,5,6,7,8,9,10,11,12,13
Primary	VISA-A score	VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.	6 month
Secondary	VISA-A score		3, 12, 24 months
Secondary	Global rating scale for recovery	11 point box scale	1, 2, 3, 6, 12, 24 months
Secondary	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)	3, 6, 12, 24 months