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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03913546
Other study ID # CEI/HU/2018/09
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2022
Est. completion date October 2022

Study information

Verified date May 2024
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2022
Est. primary completion date July 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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:
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

Locations

Country Name City State
Spain University of Alcalá Alcalá De Henares

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
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