Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial)

University of Malaga

Status: Not yet enrolling

Conditions: Tendinopathy

Treatments: Other: Experimental exercise programme; Other: Best current practice exercise programme

Study type: Interventional

Funder types: Other

Identifiers

NCT03853122

DOSIS&TENDON

Details and patient eligibility

About

This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Half of the participants will receive the experimental intervention, while the other half will receive the best current practice.

Full description

The current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by Cook and Purdam (Cook & Purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (Mellor et al., 2018). However, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities.

Therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. Moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;
2. Pain duration for at least one month.

Exclusion criteria

1. Corticosteroid injection in the studied tendon in the last 12 months;
2. Other injuries in the affected lower limb in the last 12 months;
3. Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;
4. Tendinous rupture history in the affected lower limb;
5. Systemic diseases such as rheumatic arthritis or diabetes mellitus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Best current practice exercise programme

Active Comparator group

Description:

Therapeutic physical exercise, best current practice: Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: two exercises performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group). Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: one exercise performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group). Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL, from daily to twice weekly, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).

Treatment:

Other: Best current practice exercise programme

Experimental exercise programme

Experimental group

Description:

Therapeutic physical exercise common for the three locations (Achilles, patellar and gluteal tendinopathy), based on an individual dosage and neuromuscular adaptations (five stages): Strength training four exercises, once daily, three times/week, 14 weeks Aerobic training: Once daily, twice weekly

Treatment:

Other: Experimental exercise programme