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Introduction: Cycling represents a very important level of practice, being among the most practiced sports in Spain. As in any other sport discipline, its practice is associated with the appearance of overloads and sports injuries. Specifically, the 2 most affected areas are the lumbar and knee areas, with an annual prevalence of 58% and 36%, respectively. There is no clear hypothesis to explain the low back pain associated with the practice of cycling, but several authors agree that it may be due to holding an inverted posture of the rachis and the characteristics associated with this sport: long duration, static posture, high intensities, vibrations generated by the terrain, and so forth. The project proposes to analyze the acute effect of a long-lasting bicycle trip (3 hours) on the muscles involved in low back and knee pain, see, lumbar paravertebral, quadriceps and hamstrings, by means of tensiomyography (TMG).
Objectives: the main objective of this study is to evaluate the behavior of the mechanical characteristics of the lower back and thigh muscles, by means of tensiomyography, in amateur cyclists after an acute effort on road and mountain bikes, and to study their possible relationship with low back pain (LBP).
A crossover randomized controlled trial. The participation in the study requires only 2 assistances to the data takings that will be developed in the training laboratory of the Faculty of Sciences of Physical Activity and Sport of the European University. 40 amateur cyclists will be randomly assigned to carry out each (2) conditions of intervention: a road bike time trial (CA) and a mountain bike time trial (MT) separated by 7 days washout. *Randomization marks the order in which participants are subjected to an intervention condition or other.
These sessions will begin with an initial assessment, which will be carried out: an anthropometric assessment (height and weight), followed to an evaluation of the tensiomyographic variable maximal radial displacement (Dm) over the thigh muscles: vastus medialis (VM), rectus femoris (RF), vastus lateralis (VL), biceps femoris (BF), and erector spinae (EE) at the lumbar level, before and after an acute effort (> 3 hours) in CA and MT bicycle. Respect to pain assessment, it will be measured the intensity pain perception on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale; the pressure pain threshold (PPT) with a manual mechanical algometer; and the functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Road Cycling first, then Mountain Biking | Active Comparator | First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking). |
|
| Mountain Biking first, then Road Cycling | Active Comparator | First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 hours Road Cycling Time Trial | Other | The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. |
| Measure | Description | Time Frame |
|---|---|---|
| Low Back Pain Perception (LBPP) | This variable records the intensity pain perceived on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale (NPRS). This is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The LBPP was measured before and after completing each time trial. | Change between Baseline and 3 hours |
| Maximal Radial Displacement (Dm) | The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in milimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect. | Baseline and after 3 hours |
| Pressure Pain Threshold (PPT) | Measured from 0 to 10kg/cm2 with a manual mechanical algometer (FDK/FDN, Wagner Instruments, 1217 Greenwich, CT 06836), which has bilaterally shown an excellent reliability, reproducibility, and sensitivity on the lumbar erector spinae muscles. | Baseline and after 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Roland-Morris Questionnaire (RMQ) | The functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability. | Baseline |
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Inclusion Criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrid | Villaviciosa de Odón | Madrid | 28670 | Spain |
They were required to attend on 2 different occasions to our installation, both spaced a week apart as washout.
In total, 40 participants were randomly assigned to their Arm/Group, in which the intervention was administered in 2 different sequences of intervention: 1) Road Cycling first, then Mountain Biking; and 2) Mountain Biking first, then Road Cycling.
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| ID | Title | Description |
|---|---|---|
| FG000 | Road Cycling First, Then Mountain Biking | They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT. |
| FG001 | Mountain Biking First, Then Road Cycling. | They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Regardless of the Arm/Group in which the participants were initially assigned, all participants received all interventions. Therefore they are represented combined into one single Arm/Group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Low Back Pain Perception (LBPP) | This variable records the intensity pain perceived on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale (NPRS). This is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The LBPP was measured before and after completing each time trial. | Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years | Posted | Mean | Standard Deviation | units on a scale | Change between Baseline and 3 hours |
|
All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Road Cycling First, Then Mountain Biking | They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerson Garrosa Martín | Universidad Europea de Madrid | +34 663 294 774 | 0034 | g.garrosa@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 11, 2019 | Mar 12, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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A cross-over study with a single group (n = 40) of amateur cyclists subjected to each 2 different intervention conditions: a road bike time trial (CA) and a mountain bike time trial (MT).
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| 3 hours Mountain Biking Time Trial | Other | The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Mountain Biking First, Then Road Cycling | First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty. |
|
|
| Primary | Maximal Radial Displacement (Dm) | The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in milimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect. | Posted | Mean | Standard Deviation | mm | Baseline and after 3 hours |
|
|
|
| Primary | Pressure Pain Threshold (PPT) | Measured from 0 to 10kg/cm2 with a manual mechanical algometer (FDK/FDN, Wagner Instruments, 1217 Greenwich, CT 06836), which has bilaterally shown an excellent reliability, reproducibility, and sensitivity on the lumbar erector spinae muscles. | Posted | Mean | Standard Deviation | kg/cm^2 | Baseline and after 3 hours |
|
|
|
| Secondary | Roland-Morris Questionnaire (RMQ) | The functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Mountain Biking First, Then Road Cycling | They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Score of 3 |
|
| Score of 4 |
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| Score of 5 |
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| Score of 6 |
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| Score of more than 6 |
|