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Completed

NCT Number: NCT03089008

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.

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Key information

Conditions

Achillodynia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eccentric exercises

Other

Stretching exercises

Other

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Important dates

Study start
1999
Primary completion
2000
Study completion
2007
First posted
Mar 24, 2017
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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