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
Health condition
Chronic midportion achilles tendinopathy
Research involving
Sponsors and support
Intervention
- Movement therapy
Outcome measures
Primary outcome
Primary outcome is the change of the validated and disease-specific Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire after 12 weeks.
Secondary outcome
We will explore baseline characteristics (personal characteristics, additional questionnaires and results of functional tests) that can aid in predicting the prognosis for these patients. Other secondary outcome measures include pain during functional tests, patient satisfaction, adherence of the exercise program and return to pre-injury sports activities.
Background summary
Study objective
Study design
Study population: Patients aged 18-70 years diagnosed with chronic midportion Achilles tendinopathy.
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.
Primary outcome is the change of the validated and disease-specific Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire after 12 weeks.
Secondary, we will explore baseline characteristics (personal characteristics, additional questionnaires and results of functional tests) that can aid in predicting the prognosis for these patients. Other secondary outcome measures include pain during functional tests, patient satisfaction, adherence of the exercise program and return to pre-injury sports activities.
The patients will be analyzed by intention-to-treat. To test for the effect of treatment on the between-group difference in primary outcome (VISA-A score), we will use a general linear model. Changes from baseline to 12 weeks follow-up will be included in the model. Adjustments will be made for those baseline variables that influence the primary outcome with P < .10. We will evaluate secondary outcomes using a generalized estimating equations model.
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
Hospital visits will not result in healthcare costs for the patient.
The eccentric calf muscle exercises commonly cause pain. Patients in both groups will be informed they can expect muscle soreness.
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
Age
Inclusion criteria
1. Clinical diagnosis of "chronic midportion Achilles tendinopathy" based on the following criteria: a. Pain on palpation 2-7 cm above the insertion of the Achilles tendon (“midportion”) b. Achilles tendon symptoms for at least 2 months 2. Age 18-70 years
Exclusion criteria
1. Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneus) 2. Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and/or palpable "gap") 3. Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance) 4. Clinical suspicion of sural nerve pathology (sensitive disorder in the area of the sural nerve) 5. Clinical suspicion of peroneal subluxation (visible luxation of the tendons of the Peroneal muscles at the lateral malleolus in combination with localized pain) 6. Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins 7. Patients known to have the following disorders: spondylarthropathy, gout, familial hypercholesterolemia and rheumatoid arthritis 8. The patient already performed heavy load 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 9. Presence of pregnancy 10. A condition that prevents the patients from executing an active rehabilitation program 11. Patient has received an injection for this injury 12. Patient has received surgical intervention for this injury 13. Patient has already one site (left or right) included in this study 14. Patient does not wish, for whatever reason, to undergo one of the two treatments 15. Patient has a history of Achilles tendon rupture on the affected
Design
Recruitment
IPD sharing statement
Postzone P5-P, kamer P5-22
Postbus 9600
2300 RC Leiden
071 526 3241/ 071 526 6963
metc-ldd@lumc.nl
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 |
|---|---|
| NTR-new | NL7861 |
| Other | NL67061.075.18 |