Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles

June 27, 2019 updated by: Gerson Garrosa Martín, Universidad Europea de Madrid

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).

Study Overview

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Villaviciosa De Odón, Madrid, Spain, 28670
        • Universidad Europea de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Be a man
  • Aged between 18 and 55 years.
  • Minimum experience in the practice of cycling over 3 years
  • Accumulate at least 200 hours of training each year.
  • Not having received specific treatment in the musculature evaluated in the last 4 weeks, or being subjected to any treatment at present.
  • No pathology diagnosed in the anatomical regions interested in the study (lumbar, thigh, hip or knee).
  • Sign the informed consent.

Exclusion criteria

  • Have had strenuous exercise in the previous 48 hours
  • Having taken energy drinks in the last 48 hours
  • Have ingested alcohol or caffeine in the 3 hours prior to taking data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Road Cycling first, then Mountain Biking
First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).
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.
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.
Active Comparator: 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).
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low Back Pain Perception (LBPP)
Time Frame: Change between Baseline and 3 hours
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)
Time Frame: Baseline and after 3 hours
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)
Time Frame: Baseline and after 3 hours
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland-Morris Questionnaire (RMQ)
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2017

Primary Completion (Actual)

May 5, 2018

Study Completion (Actual)

June 13, 2018

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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