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Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists

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ClinicalTrials.gov Identifier: NCT03913546
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Germain, University of Alcala

Brief Summary:
The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.

Condition or disease Intervention/treatment Phase
Manual Therapies Procedure: Spinal manipulative therapy Other: Sham spinal manipulative therapy Not Applicable

Detailed Description:
The present study will follow a parallel, pre-post design. The aim will be to determine the acute effects of spinal manipulation therapy (SMT) on different neuromuscular properties of recreational cyclists. Specifically, the investigators will measure the maximum force production capacity and muscle activation of the knee extensors concomitantly during a maximal voluntary contraction, as well as the maximum and mean power attained during a Wingate cycling test (i.e., 30 seconds 'all out'). Participants will undergo the tests on two different occasions separated by at least 48 hours and a maximum of 2 weeks. The same tests will be conducted in both testing sessions, but participants will be randomly assigned into two groups (sham or actual SMT) immediately before the second testing session.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, parallel, pre-post study design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will receive either a sham procedure or the actual intervention. The researchers in charge of outcome assessment and statistical analysis will be blinded to the allocation of participants.
Primary Purpose: Other
Official Title: Acute Effects of Spinal Manipulation on the Neuromuscular Performance of Amateur Cyclists: Pilot Study
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Sham Comparator: Sham spinal manipulation
Participants in the 'sham' group will receive a sham mechanical thrust (force set at level 0) instead of an actual one. In the force level 0, no excursion of the stylus occurs, but the instrument produces the same clicking sound as in the actual SMT condition. Therefore, the subject does not distinguish between intervention or placebo.
Other: Sham spinal manipulative therapy
Participants in the sham SMT group will undergo a protocol identical to the actual one, with the exception that a sham mechanical thrust (force set at level 0) will be delivered to the targeted areas. In the force level 0 no excursion of the stylus occurs, but the instrument produces the same clicking sound as in the actual SMT condition

Experimental: Actual spinal manipulation
Participants in the actual actual spinal manipulative therapy (SMT) group will be assessed through the Activator basic method. SMT will be performed with the Activator IV Adjusting Instrument (Activator Methods International, Phoenix, AZ) varying the force level depending on the adjusted segment.
Procedure: Spinal manipulative therapy
Participants in the actual spinal manipulative therapy group will be assessed through the activator basic method protocol. SMT will be performed with an Activator IV (Activator Methods International, Phoenix, AZ) setting the force at level 3 for the low thoracic spine (T7-T12), and level 4 for the lumbar spine and pelvis.
Other Names:
  • Chiropractic manipulation
  • Spine thrust manipulation




Primary Outcome Measures :
  1. Maximal force [ Time Frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure) ]
    Peak force registered during an isometric maximal voluntary contraction of the knee extensors.

  2. Voluntary activation [ Time Frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure) ]
    Electromyographic activity of the vastus lateralis muscle registered during an isometric maximal voluntary contraction of the knee extensors.

  3. Peak power [ Time Frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure) ]
    Peak power registered during a 30-second Wingate anaerobic cycling test

  4. Mean power [ Time Frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure) ]
    Mean power registered during a 30-second Wingate anaerobic cycling test



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Will be recruited from three different local triathlon and cycling clubs.
  • Will have to cycle at least 4 hours per week during the preceding 3 months, and to have a cycling experience greater than 2 years

Exclusion Criteria:

  • Having suffered an injury in the month before the study that precluded regular exercise practice
  • Having suffered any type of spine injury before the study
  • Having previously received Spinal Manipulation Therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913546


Contacts
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Contact: Francisco J Germain, MD, PhD 0034918854525 francisco.germain@uah.es
Contact: Pedro de la Villa, MD, PhD 0034918854525 pedro.villa@uah.es

Locations
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Spain
University of Alcalá Recruiting
Alcalá De Henares, Spain, 28871
Contact: Pedro de la Villa, MD, PhD    0034918854525    pedro.villa@uah.es   
Sponsors and Collaborators
University of Alcala
Investigators
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Study Director: Pedro de la Villa, MD, PhD University of Alcalá
  Study Documents (Full-Text)

Documents provided by Francisco Germain, University of Alcala:

Publications:
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Responsible Party: Francisco Germain, Associate professor, University of Alcala
ClinicalTrials.gov Identifier: NCT03913546     History of Changes
Other Study ID Numbers: CEI/HU/2018/09
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Germain, University of Alcala:
neuromuscular properties
strength
power
performance