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

University of Malaga0 sites104 target enrollmentJune 1, 2024

ConditionsTendinopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tendinopathy
Sponsor: University of Malaga
Enrollment: 104
Primary Endpoint: Victorian Institute of Sport Assessment (VISA) questionnaire POST
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2024

End Date

December 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Malaga

Responsible Party

Principal Investigator

Dr. Antonio I Cuesta-Vargas

Director, Clinical Research

University of Malaga

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Victorian Institute of Sport Assessment (VISA) questionnaire POST

Time Frame: Post, 14 weeks after start of the intervention (when intervention is finished)

Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).

Secondary Outcomes

Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM(Short term, 7 weeks after start of the intervention)
Central Sensitization Inventory (CSI) PRE(Baseline, 1 week before start of the intervention)
Fear Avoidance Components Scale (FACS) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Fear Avoidance Components Scale (FACS) FOLLOW-UP(52 weeks after start of the intervention)
Central Sensitization Inventory (CSI) FOLLOW-UP(52 weeks after start of the intervention)
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM(Short term, 7 weeks after start of the intervention)
Lower limb Strength PRE(Short term, 7 weeks after start of the intervention)
Muscular Thickness PRE(Baseline, 1 week before start of the intervention)
Muscular Thickness POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Muscular Thickness FOLLOW-UP(52 weeks after start of the intervention)
Victorian Institute of Sport Assessment (VISA) questionnaire PRE(Baseline, 1 week before start of the intervention)
Central Sensitization Inventory (CSI) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up(52 weeks after the start of the intervention)
Central Sensitization Inventory (CSI) SHORT TERM(Short term, 7 weeks after start of the intervention)
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE(Baseline, 1 week before start of the intervention)
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP(52 weeks after start of the intervention)
Lower limb Strength SHORT TERM(Short term, 7 weeks after start of the intervention)
European Quality of Life-5 Dimensions (EQ-5D) PRE(Baseline, 1 week before start of the intervention)
Lower Limb Functional Index (LLFI) PRE(Baseline, 1 week before start of the intervention)
Lower Limb Functional Index (LLFI) FOLLOW-UP(52 weeks after start of the intervention)
Lower limb Strength POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Fear Avoidance Components Scale (FACS) PRE(Baseline, 1 week before start of the intervention)
Fear Avoidance Components Scale (FACS) SHORT TERM(Short term, 7 weeks after start of the intervention)
European Quality of Life-5 Dimensions (EQ-5D) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP(52 weeks after start of the intervention)
European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM(Short term, 7 weeks after start of the intervention)
Lower Limb Functional Index (LLFI) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Lower Limb Functional Index (LLFI) SHORT TERM(Short term, 7 weeks after start of the intervention)
Pressure Pain Threshold POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Lower limb Strength FOLLOW-UP(52 weeks after start of the intervention)
Muscular Thickness SHORT TERM(Short term, 7 weeks after start of the intervention)
Pressure Pain Threshold PRE(Baseline, 1 week before start of the intervention)
Pressure Pain Threshold SHORT TERM(Short term, 7 weeks after start of the intervention)
Pain at rest measured with Visual Analogue Scale (VAS) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP(52 weeks after start of the intervention)
Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM(Short term, 7 weeks after start of the intervention)
Lower limb Strength measured with hand-held dinamometer PRE(Baseline, 1 week before start of the intervention)
Pressure Pain Threshold FOLLOW-UP(52 weeks after start of the intervention)
Pain at rest measured with Visual Analogue Scale (VAS) PRE(Baseline, 1 week before start of the intervention)
Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM(Short term, 7 weeks after start of the intervention)
Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP(52 weeks after start of the intervention)
Treatment satisfaction PRE(Baseline, 1 week before start of the intervention)
Treatment satisfaction POST(Post, 14 weeks after start of the intervention (when intervention is finished))
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE(Baseline, 1 week before start of the intervention)
Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE(Baseline, 1 week before start of the intervention)
Pain during activity (running) measured with Visual Analogue Scale (VAS) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Treatment satisfaction SHORT-TERM(Short term, 7 weeks after start of the intervention)
Lower limb Strength measured with hand-held dinamometer POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Lower limb Strength measured with hand-held dinamometer SHORT TERM(Short term, 7 weeks after start of the intervention)
Lower limb Strength measured with hand-held dinamometer FOLLOW UP(52 weeks after start of the intervention)
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
Treatment satisfaction FOLLOW UP(52 weeks after start of the intervention)
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)(52 weeks after start of the intervention)