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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Therapeutic Physical Exercise programme based on the protocol of Afredson (for Achilles and patellar tendinopathies) and LEAP (for gluteal tendinopathy). Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetitions of two eccentric exercises Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetions of one eccentric exercise Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL: an exercise programme divided into stages with progression in different exercises, volumes and loads
Therapeutic Physical Exercise programme structured in five stages oriented to specific neuromuscular adaptations based on the characteristics of the neuromuscular system, once daily, three times/week, sets, repetitions and load based on individually performed tests.
Victorian Institute of Sport Assessment (VISA) questionnaire POST
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).
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Victorian Institute of Sport Assessment (VISA) questionnaire PRE
Visa-A model for Achilles tendon, Visa-P model for Patellar tendon, Visa-G model for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
Time frame: Baseline, 1 week before start of the intervention
Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM
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).
Time frame: Short term, 7 weeks after start of the intervention
Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up
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).
Time frame: 52 weeks after the start of the intervention
Central Sensitization Inventory (CSI) PRE
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Time frame: Baseline, 1 week before start of the intervention
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Central Sensitization Inventory (CSI) SHORT TERM
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Time frame: Short term, 7 weeks after start of the intervention
Central Sensitization Inventory (CSI) POST
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Central Sensitization Inventory (CSI) FOLLOW-UP
Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)
Time frame: 52 weeks after start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of \< 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that \> 130 points indicates a high disability
Time frame: Baseline, 1 week before start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of \< 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that \> 130 points indicates a high disability
Time frame: Short term, 7 weeks after start of the intervention
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of \< 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that \> 130 points indicates a high disability
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP
OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of \< 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that \> 130 points indicates a high disability
Time frame: 52 weeks after start of the intervention
Fear Avoidance Components Scale (FACS) PRE
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Time frame: Baseline, 1 week before start of the intervention
Fear Avoidance Components Scale (FACS) SHORT TERM
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Time frame: Short term, 7 weeks after start of the intervention
Fear Avoidance Components Scale (FACS) POST
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Fear Avoidance Components Scale (FACS) FOLLOW-UP
The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.
Time frame: 52 weeks after start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) PRE
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Time frame: Baseline, 1 week before start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Time frame: Short term, 7 weeks after start of the intervention
European Quality of Life-5 Dimensions (EQ-5D) POST
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."
Time frame: 52 weeks after start of the intervention
Lower Limb Functional Index (LLFI) PRE
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Time frame: Baseline, 1 week before start of the intervention
Lower Limb Functional Index (LLFI) POST
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower Limb Functional Index (LLFI) SHORT TERM
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Time frame: Short term, 7 weeks after start of the intervention
Lower Limb Functional Index (LLFI) FOLLOW-UP
The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).
Time frame: 52 weeks after start of the intervention
Lower limb Strength PRE
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Time frame: Short term, 7 weeks after start of the intervention
Lower limb Strength SHORT TERM
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Time frame: Short term, 7 weeks after start of the intervention
Lower limb Strength POST
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower limb Strength FOLLOW-UP
Assessment of the isometric strength in the leg press machine using a s-beam load cell
Time frame: 52 weeks after start of the intervention
Muscular Thickness PRE
Measurement of the muscular thickness (in cm) by Ultrasonography
Time frame: Baseline, 1 week before start of the intervention
Muscular Thickness SHORT TERM
Measurement of the muscular thickness (in cm) by Ultrasonography
Time frame: Short term, 7 weeks after start of the intervention
Muscular Thickness POST
Measurement of the muscular thickness (in cm) by Ultrasonography
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Muscular Thickness FOLLOW-UP
Measurement of the muscular thickness (in cm) by Ultrasonography
Time frame: 52 weeks after start of the intervention
Pressure Pain Threshold PRE
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Time frame: Baseline, 1 week before start of the intervention
Pressure Pain Threshold SHORT TERM
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Time frame: Short term, 7 weeks after start of the intervention
Pressure Pain Threshold POST
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Pressure Pain Threshold FOLLOW-UP
Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.
Time frame: 52 weeks after start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) PRE
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: Baseline, 1 week before start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: Short term, 7 weeks after start of the intervention
Pain at rest measured with Visual Analogue Scale (VAS) POST
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP
Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: 52 weeks after start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: Baseline, 1 week before start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: Short term, 7 weeks after start of the intervention
Pain during activity (running) measured with Visual Analogue Scale (VAS) POST
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP
Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain
Time frame: 52 weeks after start of the intervention
Treatment satisfaction PRE
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Time frame: Baseline, 1 week before start of the intervention
Treatment satisfaction SHORT-TERM
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Time frame: Short term, 7 weeks after start of the intervention
Treatment satisfaction POST
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Treatment satisfaction FOLLOW UP
Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".
Time frame: 52 weeks after start of the intervention
Lower limb Strength measured with hand-held dinamometer PRE
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Time frame: Baseline, 1 week before start of the intervention
Lower limb Strength measured with hand-held dinamometer POST
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Lower limb Strength measured with hand-held dinamometer SHORT TERM
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Time frame: Short term, 7 weeks after start of the intervention
Lower limb Strength measured with hand-held dinamometer FOLLOW UP
Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.
Time frame: 52 weeks after start of the intervention
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE
Non invasive surface HDEMG during maximal isometric voluntary contraction performed in a leg press machine. Surface HDEMG is recorded during 20 seconds. Data obtained is analysed to extract the mean discharge rate of the motor units (in fires per second) and the recruitment and derecruitment threshold (in Nw). This variable will only be assessed in a randomly selected subgroup of each arm.
Time frame: Baseline, 1 week before start of the intervention
HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST
Non invasive surface HDEMG during maximal isometric voluntary contraction performed in a leg press machine. Surface HDEMG is recorded during 20 seconds. Data obtained is analysed to extract the mean discharge rate of the motor units (in fires per second) and the recruitment and derecruitment threshold (in Nw). This variable will only be assessed in a randomly selected subgroup of each arm.
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Time frame: Baseline, 1 week before start of the intervention
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Time frame: Short term, 7 weeks after start of the intervention
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Time frame: Post, 14 weeks after start of the intervention (when intervention is finished)
Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)
Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.
Time frame: 52 weeks after start of the intervention