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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.
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The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham spinal manipulation | Sham Comparator | 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. |
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| Actual spinal manipulation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulative therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro de la Villa, MD, PhD | University of Alcalá | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alcalá | Alcalá de Henares | 28871 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30325889 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2019 | Apr 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Randomized, parallel, pre-post study design.
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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.
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| Sham spinal manipulative therapy | 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 |
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