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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03089008
Other study ID # (KF) 01-157/98, (KF) 01-109/99
Secondary ID 1999-DP-65-RKF-1
Status Completed
Phase N/A
First received August 25, 2016
Last updated March 23, 2017
Start date January 1999
Est. completion date December 2007

Study information

Verified date March 2017
Source Copenhagen Trial Unit, Center for Clinical Intervention Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2007
Est. primary completion date July 2000
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Eccentric exercises

Stretching exercises


Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research Clinic of Sports Medicine, Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). At inclusion
Primary 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). 12 weeks
Primary 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). 39 weeks
See also
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Active, not recruiting NCT03523325 - Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women N/A
Completed NCT01343836 - Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy Phase 2/Phase 3

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