Eccentric Exercise in Treatment of Achilles Tendinopathy

Sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research (Other)
Overall Status
Completed
CT.gov ID
NCT03089008
Collaborator
Bispebjerg Hospital (Other)
45
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2
107
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Eccentric exercises
  • Other: Stretching exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Eccentric Exercise in Treatment of Achilles Tendinopathy
Study Start Date :
Jan 1, 1999
Actual Primary Completion Date :
Jul 1, 2000
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

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: Eccentric exercises

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.

Other: Stretching exercises

Outcome Measures

Primary Outcome Measures

  1. Manually assessed tenderness at inclusion [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).

  2. Change in manually assessed tenderness after 12 weeks [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).

  3. Change in manually assessed tenderness after 39 weeks [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg Hospital Copenhagen Denmark

Sponsors and Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Bispebjerg Hospital

Investigators

  • Study Chair: Per Jessen,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Copenhagen Trial Unit, Center for Clinical Intervention Research
ClinicalTrials.gov Identifier:
NCT03089008
Other Study ID Numbers:
  • (KF) 01-157/98, (KF) 01-109/99
  • 1999-DP-65-RKF-11 [CTU]
First Posted:
Mar 24, 2017
Last Update Posted:
Mar 27, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2017