Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists
NCT ID: NCT03913546
Last Updated: 2024-05-13
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2022-06-30
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
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.
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
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.
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.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 any type of spine injury before the study
* Having previously received Spinal Manipulation Therapy
18 Years
45 Years
MALE
Yes
Sponsors
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University of Alcala
OTHER
Responsible Party
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Francisco Germain
Associate professor
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
Countries
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CEI/HU/2018/09
Identifier Type: -
Identifier Source: org_study_id
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