Study Stopped
In the first tests the force meter gave an error and all the records were lost. Then came the COVID-19 pandemic. At this time we are unable to finish the study. We hope to be able to complete it by the middle of next year.
Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists
Acute Effects of Spinal Manipulation on the Neuromuscular Performance of Amateur Cyclists: Pilot Study
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 13, 2024
May 1, 2024
1 month
April 4, 2019
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Maximal force
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
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
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
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)
Study Arms (2)
Sham spinal manipulation
SHAM COMPARATORParticipants 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.
Actual spinal manipulation
EXPERIMENTALParticipants 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alcalá
Alcalá de Henares, 28871, Spain
Related Publications (1)
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.
PMID: 30325889BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pedro de la Villa, MD, PhD
University of Alcalá
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 12, 2019
Study Start
June 1, 2022
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
May 13, 2024
Record last verified: 2024-05