Back to resultsEccentric Exercise in Treatment of Achilles Tendinopathy
Primary Purpose
Achillodynia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Eccentric exercises
Stretching exercises
Sponsored by
About this trial
This is an interventional treatment trial for Achillodynia
Eligibility Criteria
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.
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Eccentric exercises
Control treatment, stretching exercises
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Manually assessed tenderness 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).
Change in manually assessed tenderness after 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).
Change in manually assessed tenderness after 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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03089008
First Posted
August 25, 2016
Last Updated
March 23, 2017
Sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborators
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03089008
Brief Title
Eccentric Exercise in Treatment of Achilles Tendinopathy
Official Title
Eccentric Exercise in Treatment of Achilles Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborators
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the present study is to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achillodynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eccentric exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Control treatment, stretching exercises
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric exercises
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Primary Outcome Measure Information:
Title
Manually assessed tenderness at inclusion
Description
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).
Time Frame
At inclusion
Title
Change in manually assessed tenderness after 12 weeks
Description
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).
Time Frame
12 weeks
Title
Change in manually assessed tenderness after 39 weeks
Description
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).
Time Frame
39 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Jessen
Official's Role
Study Chair
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data.
Learn more about this trial
Eccentric Exercise in Treatment of Achilles Tendinopathy
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