Tendinopathy
Conditions
Keywords
tendinopathy, exercise, dosage, physiotherapy
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.
Interventions
OTHERBest current practice exercise programme
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
OTHERExperimental exercise programme
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.
Sponsors
Ministry of Science and Innovation, Spain
University of Malaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors are not aware of the allocation group of the participants
Intervention model description
Randomized controlled trial, with two parallel groups (control and intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Victorian Institute of Sport Assessment (VISA) questionnaire POST | 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
| Measure | Time frame | Description |
|---|---|---|
| Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM | Short term, 7 weeks after start of the intervention | 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). |
| Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up | 52 weeks after the start of the intervention | 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). |
| Central Sensitization Inventory (CSI) PRE | Baseline, 1 week before start of the intervention | 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) |
| Central Sensitization Inventory (CSI) SHORT TERM | Short term, 7 weeks after start of the intervention | 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) |
| Central Sensitization Inventory (CSI) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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) |
| Central Sensitization Inventory (CSI) FOLLOW-UP | 52 weeks after start of the intervention | 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) |
| Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE | Baseline, 1 week before start of the intervention | 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 |
| Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM | Short term, 7 weeks after start of the intervention | 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 |
| Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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 |
| Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP | 52 weeks after start of the intervention | 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 |
| Fear Avoidance Components Scale (FACS) PRE | Baseline, 1 week before start of the intervention | 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. |
| Fear Avoidance Components Scale (FACS) SHORT TERM | Short term, 7 weeks after start of the intervention | 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. |
| Fear Avoidance Components Scale (FACS) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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. |
| Fear Avoidance Components Scale (FACS) FOLLOW-UP | 52 weeks after start of the intervention | 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. |
| European Quality of Life-5 Dimensions (EQ-5D) PRE | Baseline, 1 week before start of the intervention | 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... |
| European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM | Short term, 7 weeks after start of the intervention | 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... |
| European Quality of Life-5 Dimensions (EQ-5D) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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... |
| European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP | 52 weeks after start of the intervention | 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... |
| Lower Limb Functional Index (LLFI) PRE | Baseline, 1 week before start of the intervention | 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). |
| Lower Limb Functional Index (LLFI) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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). |
| Lower Limb Functional Index (LLFI) SHORT TERM | Short term, 7 weeks after start of the intervention | 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). |
| Lower Limb Functional Index (LLFI) FOLLOW-UP | 52 weeks after start of the intervention | 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). |
| Lower limb Strength PRE | Short term, 7 weeks after start of the intervention | Assessment of the isometric strength in the leg press machine using a s-beam load cell |
| Lower limb Strength SHORT TERM | Short term, 7 weeks after start of the intervention | Assessment of the isometric strength in the leg press machine using a s-beam load cell |
| Lower limb Strength POST | Post, 14 weeks after start of the intervention (when intervention is finished) | Assessment of the isometric strength in the leg press machine using a s-beam load cell |
| Lower limb Strength FOLLOW-UP | 52 weeks after start of the intervention | Assessment of the isometric strength in the leg press machine using a s-beam load cell |
| Muscular Thickness PRE | Baseline, 1 week before start of the intervention | Measurement of the muscular thickness (in cm) by Ultrasonography |
| Muscular Thickness SHORT TERM | Short term, 7 weeks after start of the intervention | Measurement of the muscular thickness (in cm) by Ultrasonography |
| Muscular Thickness POST | Post, 14 weeks after start of the intervention (when intervention is finished) | Measurement of the muscular thickness (in cm) by Ultrasonography |
| Muscular Thickness FOLLOW-UP | 52 weeks after start of the intervention | Measurement of the muscular thickness (in cm) by Ultrasonography |
| Pressure Pain Threshold PRE | Baseline, 1 week before start of the intervention | 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. |
| Pressure Pain Threshold SHORT TERM | Short term, 7 weeks after start of the intervention | 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. |
| Pressure Pain Threshold POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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. |
| Pressure Pain Threshold FOLLOW-UP | 52 weeks after start of the intervention | 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. |
| Pain at rest measured with Visual Analogue Scale (VAS) PRE | Baseline, 1 week before start of the intervention | Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM | Short term, 7 weeks after start of the intervention | Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain at rest measured with Visual Analogue Scale (VAS) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP | 52 weeks after start of the intervention | Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE | Baseline, 1 week before start of the intervention | Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM | Short term, 7 weeks after start of the intervention | Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain during activity (running) measured with Visual Analogue Scale (VAS) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP | 52 weeks after start of the intervention | Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain |
| Treatment satisfaction PRE | Baseline, 1 week before start of the intervention | Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being not at all satisfied and 10 being extremely satisfied. |
| Treatment satisfaction SHORT-TERM | Short term, 7 weeks after start of the intervention | Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being not at all satisfied and 10 being extremely satisfied. |
| Treatment satisfaction POST | Post, 14 weeks after start of the intervention (when intervention is finished) | Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being not at all satisfied and 10 being extremely satisfied. |
| Treatment satisfaction FOLLOW UP | 52 weeks after start of the intervention | Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being not at all satisfied and 10 being extremely satisfied. |
| Lower limb Strength measured with hand-held dinamometer PRE | Baseline, 1 week before start of the intervention | 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. |
| Victorian Institute of Sport Assessment (VISA) questionnaire PRE | Baseline, 1 week before start of the intervention | 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). |
| 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 (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. |
| Lower limb Strength measured with hand-held dinamometer FOLLOW UP | 52 weeks after start of the intervention | 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. |
| HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE | Baseline, 1 week before start of the intervention | 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. |
| HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST | Post, 14 weeks after start of the intervention (when intervention is finished) | 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. |
| Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF) | Baseline, 1 week before start of the intervention | 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. |
| 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 (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. |
Outcome results
None listed