NCT03089008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

August 25, 2016

Last Update Submit

March 23, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Eccentric exercises

EXPERIMENTAL

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

Control treatment, stretching exercises

OTHER

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

Interventions

Eccentric exercises
Control treatment, stretching exercises

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Per Jessen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

March 24, 2017

Study Start

January 1, 1999

Primary Completion

July 1, 2000

Study Completion

December 1, 2007

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plan to share data.

Locations