Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists

May 10, 2024 updated by: Francisco Germain, University of Alcala

Acute Effects of Spinal Manipulation on the Neuromuscular Performance of Amateur Cyclists: Pilot Study

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

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

  • Spain
      • Alcalá De Henares, Spain, 28871
        • University of Alcala

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
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.
On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
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
On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
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
On the control session and on the intervention session (immediately after the sham or actual SMT procedure)

Collaborators and Investigators

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

Sponsor

University of Alcala

Investigators

  • Study Director: Pedro de la Villa, MD, PhD, University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2022

Primary Completion (Estimated)

July 1, 2022

Study Completion (Estimated)

October 1, 2022

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEI/HU/2018/09

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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