Eccentric Exercise in Treatment of Achilles Tendinopathy

The purpose of the present study is to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with achillodynia for at least 3 months are randomly allocated to one of two exercise regimens. Exercise is performed daily for a 3-month period. Symptom severity is evaluated by tendon tenderness, ultrasonography, a questionnaire on pain and other symptoms, and a global assessment of improvement. Follow-up is performed at time points 3, 6, 9, 12 weeks and 1 year.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pain in the Achilles tendon area with one of the two following findings. a) Distinct tenderness of Achilles tendon with no pain in the neighboring structures. b) Ultrasonographic changes defined as local thickening of the symptomatic tendon or a globally more than 2mm thicker tendon on the sick side.
  2. Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes (as described above).

Exclusion Criteria:

  1. Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years.
  2. Other injuries in the lower extremity or the knee, which by the examining doctor was evaluated to influence the evaluation of symptoms or the ability to perform the training program.
  3. Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon.
  4. Age less than 18 years or over 70 years.
  5. Previous operation on the tendon or steroid injections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eccentric exercises
The patients were instructed to stand with straight legs on a small step, lift up on the toes, hereafter put the weight on the injured leg and slowly lower the heel as far as possible until they felt a maximal stretch of the calf muscles and/or the Achilles tendon. The exercises were repeated 15 times. Then the patients were told to repeat the exercises with semi-flexed knee. If possible the series should be repeated twice increasing to three times at each session. If pain decreased they should increase the load on the Achilles tendons by wearing a rug sack and increasing the weight of the rug sack by adding weights (5kg each). The patients were told that some pain was to be expected from the tendon during exercise, but that increasing daily pain or morning stiffness indicated that the exercises had been progressed too fast.
Other: Control treatment, stretching exercises
The patients were instructed in standing stretching exercises of the gastrocnemius (straight leg) and soleus (bended knee). The stretch was slowly increased and maintained for 30s. This stretch was to be repeated five times during each session. The patients were instructed that the stretching should be pain free, although a small degree of unpleasantness was allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manually assessed tenderness at inclusion
Time Frame: At inclusion
The tenderness of the symptomatic tendons was determined manually by applying a moderate amount of pressure (about 1 kg) with the first and second finger on each side of the tendon. The tendon was palpated 0, 1, 3, 5, 7 and 10 cm proximal to the calcaneal insertion, and at each level the tenderness score was noted according to the subjects' answers of the pain perceived (0 = none, 1 = mild, 2 = moderate and 3 = severe).
At inclusion
Change in manually assessed tenderness after 12 weeks
Time Frame: 12 weeks
The tenderness of the symptomatic tendons was determined manually by applying a moderate amount of pressure (about 1 kg) with the first and second finger on each side of the tendon. The tendon was palpated 0, 1, 3, 5, 7 and 10 cm proximal to the calcaneal insertion, and at each level the tenderness score was noted according to the subjects' answers of the pain perceived (0 = none, 1 = mild, 2 = moderate and 3 = severe).
12 weeks
Change in manually assessed tenderness after 39 weeks
Time Frame: 39 weeks
The tenderness of the symptomatic tendons was determined manually by applying a moderate amount of pressure (about 1 kg) with the first and second finger on each side of the tendon. The tendon was palpated 0, 1, 3, 5, 7 and 10 cm proximal to the calcaneal insertion, and at each level the tenderness score was noted according to the subjects' answers of the pain perceived (0 = none, 1 = mild, 2 = moderate and 3 = severe).
39 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Per Jessen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

July 1, 2000

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • (KF) 01-157/98, (KF) 01-109/99
  • 1999-DP-65-RKF-11 [CTU]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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