To investigate the difference in effectiveness between the Alfredson eccentric and the Silbernagel concentric-eccentric exercise program on patient-reported function and pain during sports in patients with chronic mid-portion AT after 12 weeks.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures for this study will be patient-reported function
in daily activities and sport (measured with the Dutch version of the Victorian
Institute of Sport Assessment * Achilles questionnaire) and pain during sports
activities (measured with a visual analog scale) after 12 weeks.
Secondary outcome
Secondary outcome measures will be pain during daily activities, morning
stiffness, perceived recovery, quality of life, and functional outcome measures
(jumping height and plantar flexor endurance). Furthermore, differences in
primary and secondary outcome measures in the mid-term and long term will be
investigated, and the association between baseline variables and level of
improvement will be investagated. Finally, a cost-effectiveness analysis
between both exercise programs will be conducted.
Background summary
Mid-portion Achilles tendinopathy (AT) is a common overuse injury of the lower
extremity, often challenging for patients and therapists. Exercise therapy
(i.e. tendon loading) is considered crucial in conservative management, but the
most effective exercise program is unknown. Alfredson*s eccentric program and
Silbernagel*s concentric-eccentric program have both shown beneficial results
in the treatment of AT, but it is unknown whether any program is superior for
use in clinical practice.
Study objective
To investigate the difference in effectiveness between the Alfredson eccentric
and the Silbernagel concentric-eccentric exercise program on patient-reported
function and pain during sports in patients with chronic mid-portion AT after
12 weeks.
Study design
Prospective multicenter single blind randomized controlled trial
Intervention
Two exercise programs will be compared. The first is the Alfredson eccentric
exercise program, in which participants perform eccentric heel-drops on their
injured leg, twice daily, for three sets of 15 repetitions, and both with a
straight and bent knee (i.e. 180 repetitions per day). The other program is the
Silbernagel concentric-eccentric program, in which participants perform various
2-legged and 1-legged heel-raising exercises, for three sets of 15 repetitions,
but in this program exercises are only performed once daily.
Study burden and risks
There are no known risk factors for participation in this study, and research
has demonstrated no adverse effects for (eccentric) training in AT.
Participants will be assessed at baseline, 12 weeks, and at 6 and 12 months. At
baseline, several demographic and anthropometric data will be collected.
Baseline and follow-up assessment comprises several questionnaires on
patient-reported function, pain, morning stiffness, perceived recovery, and
quality of life. Furthermore, several physical tests will be performed: a
countermovement jump to investigate jumping height, a heel-raise test to
evaluate plantar flexor endurance, and isometric strength measurements of the
hip abductors, extensors, and external rotators. Participants are asked to keep
their exercise compliance during the intervention period in a diary, and data
on injury-related medical costs will be collected though a questionnaire at
follow-up assessments (cost-effectiveness).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Clinical diagnosis of unilateral mid-portion Achilles tendinopathy (Achilles tendon pain and swelling 2-7 cm from calcaneal insertion);
- Duration of symptoms at least three months;
- Age 18-65 years of age;
- Participating in sport involving Achilles tendon loading (i.e. running and/or jumping);
- Able to comply with both exercise programs.
Exclusion criteria
- Bilateral symptoms;
- Diagnosis of insertional Achilles tendinopathy (insertion of Achilles tendon onto posterior aspect of the calcaneus);
- Washout period of < four weeks from other treatments;
- Corticosteroid injections in the region of the Achilles tendon in the previous 12 months;
- Other lower limb injuries in previous 12 months;
- Previous surgery in the affected limb in the previous 12 months;
- History of Achilles tendon rupture in affected limb;
- Systemic diseases, such as rheumatoid arthritis and diabetes mellitus.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56035.041.15 |
| OMON | NL-OMON20566 |