To evaluate the effectiveness of eccentric calf muscle exercise therapy compared to strength training of the upper extremities (control group) in patients with chronic midportion Achilles tendinopathy.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the validated and disease-specific Victorian Institute of
Sports Assessment-Achilles (VISA-A) questionnaire after 12 weeks.
Secondary outcome
Pain during functional tests
Pain during activities of daily living
Pain during sports
Patient satisfaction
Return to sport
Adherence to the exercise therapy protocol
adherence of the exercise program and return to pre-injury sports activities.
Background summary
Both in athletes and inactive individuals, chronic midportion Achilles
tendinopathy is a common problem, and limits patients in sports and daily
activities. Chronic midportion Achilles tendinopathy is characterized by
structural disorganization of the tendon collagen that alters the loading
capacity. According to the current Dutch multidisciplinary guideline, painful
eccentric calf muscle exercise therapy is recommended as first treatment of
choice with the aim to decrease pain, restore function and tendon structure on
the longer term. A recent systematic review showed, however, that other forms
of calf muscle exercise therapy are equal to eccentric exercises for this
patient group. It is, however, unknown whether these painful calf muscle
exercises are more effective than strengthening exercises that are not related
to the affected musculotendinous unit. There are currently no studies with a
proper control group to answer this research question. An adequate and
innovative study design is needed to determine whether painful calf muscle
exercises are necessary for this patient group. The hypothesis is that
eccentric calf muscle exercise therapy (usual care) is more effective than
exercise therapy of the upper extremities.
Study objective
To evaluate the effectiveness of eccentric calf muscle exercise therapy
compared to strength training of the upper extremities (control group) in
patients with chronic midportion Achilles tendinopathy.
Study design
Single-blind, prospective, randomized controlled, single center trial. The
study will be performed at the Sports Medicine Department, Isala hospital
Zwolle, the Netherlands.
Intervention
One group will be instructed to perform a daily home-based 12-week heavy load
eccentric calf muscle exercise program. The other group will be instructed to
perform a daily home-based 12- week heavy load exercise program for the upper
extremities. Both groups will receive advices for load management according to
the pain-monitoring model, which is also part of the current usual care.
Study burden and risks
The burden of participation consists of completing a total of two hospital
visits for inclusion at baseline and follow-up at 12 weeks. Additionally,
patients will complete an online questionnaire at three additional time points.
Adherence to the exercise protocol will be asked on a weekly basis using a
short digital questionnaire during 12 weeks of treatment.
Hospital visits will not result in healthcare costs for the patient.
No drugs will be administered in the context of this study.
No adverse events are to be expected resulting from both exercise regimens
under evaluation. Both exercise therapies are safe and currently being used as
usual care for chronic midportion Achilles tendinopathy and shoulder injuries.
Therefore, the burden and risks for patients participating are limited
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Pain on palpation 2-7 cm above the insertion of the Achilles tendon (*midportion*)
Achilles tendon symptoms for at least 2 months
Age 18-70 years
Exclusion criteria
Clinical suspicion of other disorders as insertional disorders, Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
History of Achilles tendon rupture on the affected side, spondylarthropathy, gout, familial hypercholesterolemia and rheumatoid arthritis
Patient has received an injection or surgical intervention for this injury, or already performed eccentric calf muscle exercises for >=4 weeks with a complete adherence to the protocol or a comparable absolute number of exercise sets (n = 5040) in the previous year
Presence of pregnancy
Patient is nog able or does not wish to participate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67061.075.18 |