- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089008
Eccentric Exercise in Treatment of Achilles Tendinopathy
March 23, 2017 updated by: Copenhagen Trial Unit, Center for Clinical Intervention Research
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
Intervention / Treatment
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
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Copenhagen, Denmark
- Bispebjerg Hospital
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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:
- 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.
- Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes (as described above).
Exclusion Criteria:
- Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years.
- 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.
- Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon.
- Age less than 18 years or over 70 years.
- 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.
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|
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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.
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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).
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At inclusion
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Change in manually assessed tenderness after 12 weeks
Time Frame: 12 weeks
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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).
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12 weeks
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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
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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
Additional Relevant MeSH Terms
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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