Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists

NCT ID: NCT03913546

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Manual Therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel, pre-post study design.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type SHAM_COMPARATOR

Sham spinal manipulative therapy

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Spinal manipulative therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type OTHER

Other Intervention Names

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Chiropractic manipulation Spine thrust manipulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Francisco Germain

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro de la Villa, MD, PhD

Role: STUDY_DIRECTOR

University of Alcalá

Locations

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University of Alcalá

Alcalá de Henares, , Spain

Site Status

Countries

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Spain

References

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Valenzuela PL, Pancorbo S, Lucia A, Germain F. Spinal Manipulative Therapy Effects in Autonomic Regulation and Exercise Performance in Recreational Healthy Athletes: A Randomized Controlled Trial. Spine (Phila Pa 1976). 2019 May 1;44(9):609-614. doi: 10.1097/BRS.0000000000002908.

Reference Type BACKGROUND
PMID: 30325889 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CEI/HU/2018/09

Identifier Type: -

Identifier Source: org_study_id

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