Clinical trial NCT03853122: Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial)
Official title: Effect of a Common Exercise Programme With an Individualized Progression Criterion Based on the Measurement of Neuromuscular Capacity Versus Eccentric Training for Lower Limb Tendinopathies (MaLaGa Trial): Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tendinopathy
Keywords: tendinopathy
exercise
dosage
physiotherapy
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2019-02-25
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, with two parallel groups (control and intervention)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Victorian Institute of Sport Assessment (VISA) questionnaire POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary outcomes:
measure: Victorian Institute of Sport Assessment (VISA) questionnaire PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up
timeFrame: 52 weeks after the start of the intervention
measure: Central Sensitization Inventory (CSI) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Central Sensitization Inventory (CSI) SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Central Sensitization Inventory (CSI) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Central Sensitization Inventory (CSI) FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Fear Avoidance Components Scale (FACS) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Fear Avoidance Components Scale (FACS) SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Fear Avoidance Components Scale (FACS) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Fear Avoidance Components Scale (FACS) FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: European Quality of Life-5 Dimensions (EQ-5D) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: European Quality of Life-5 Dimensions (EQ-5D) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Lower Limb Functional Index (LLFI) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Lower Limb Functional Index (LLFI) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Lower Limb Functional Index (LLFI) SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Lower Limb Functional Index (LLFI) FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Lower limb Strength PRE
timeFrame: Short term, 7 weeks after start of the intervention
measure: Lower limb Strength SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Lower limb Strength POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Lower limb Strength FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Muscular Thickness PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Muscular Thickness SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Muscular Thickness POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Muscular Thickness FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Pressure Pain Threshold PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Pressure Pain Threshold SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Pressure Pain Threshold POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Pressure Pain Threshold FOLLOW-UP
timeFrame: 52 weeks after start of the intervention
measure: Pain at rest measured with Visual Analogue Scale (VAS) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Pain at rest measured with Visual Analogue Scale (VAS) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP
timeFrame: 52 weeks after start of the intervention
measure: Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Pain during activity (running) measured with Visual Analogue Scale (VAS) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP
timeFrame: 52 weeks after start of the intervention
measure: Treatment satisfaction PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Treatment satisfaction SHORT-TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Treatment satisfaction POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Treatment satisfaction FOLLOW UP
timeFrame: 52 weeks after start of the intervention
measure: Lower limb Strength measured with hand-held dinamometer PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: Lower limb Strength measured with hand-held dinamometer POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Lower limb Strength measured with hand-held dinamometer SHORT TERM
timeFrame: Short term, 7 weeks after start of the intervention
measure: Lower limb Strength measured with hand-held dinamometer FOLLOW UP
timeFrame: 52 weeks after start of the intervention
measure: HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE
timeFrame: Baseline, 1 week before start of the intervention
measure: HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Baseline, 1 week before start of the intervention
measure: Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Short term, 7 weeks after start of the intervention
measure: Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Post, 14 weeks after start of the intervention (when intervention is finished)
measure: Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 52 weeks after start of the intervention
Other outcomes:
Locations:
Study officials:
References:
citation: Escriche-Escuder A, Cuesta-Vargas AI, Casana J. Effect of a common exercise programme with an individualised progression criterion based on the measurement of neuromuscular capacity versus current best practice for lower limb tendinopathies (MaLaGa trial): a protocol for a randomised clinical trial. BMJ Open. 2021 Aug 17;11(8):e046729. doi: 10.1136/bmjopen-2020-046729.