Manual TherapiesNCT03913546
Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists
A study testing Spinal manipulative therapy in people with Manual Therapies, run by University of Alcala at 1 site in Spain.
Trial summary
The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Manual Therapies
- What is being tested?
- Spinal manipulative therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Spinal Manipulation on the Neuromuscular Performance of Amateur Cyclists: Pilot Study
The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.
Read the detailed 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.
- Conditions
- Manual Therapies
- Being tested
- Spinal manipulative therapy, Sham spinal manipulative therapy
- Keywords
- neuromuscular properties, strength, power, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulative therapyProcedure or surgery
Also called Chiropractic manipulation, Spine thrust manipulation
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 therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sham spinal manipulative therapy |
| 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. Receives: Procedure: Spinal manipulative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal force
Peak force registered during an isometric maximal voluntary contraction of the knee extensors.
Measured: 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.
Measured: 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
Measured: 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
Measured: On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study startJun 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Manual TherapiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, pre-post study design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Germain, University of Alcala
- Investigators
- Pedro de la Villa, MD, PhD, Study director, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913546
- Sponsor's protocol ID
- CEI/HU/2018/09
- Status last verified
- May 2024
- First submitted
- 4 Apr 2019
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30325889
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Spinal Manipulation on the Neuromuscular Performance of Amateur Cyclists: Pilot Study
- ClinicalTrials.gov ID
- NCT03913546
- Acronym / sponsor ID
- CEI/HU/2018/09
- Conditions
- Manual Therapies
- Keywords
- neuromuscular properties, strength, power, performance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel, pre-post study design.
| Arm | Type | Receives |
|---|---|---|
| Sham spinal manipulation | Sham comparator | Other: Sham spinal manipulative therapyParticipants 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 | Experimental | Procedure: Spinal manipulative therapyParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal manipulative therapyAlso: Chiropractic manipulation, Spine thrust manipulationParticipants 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. | Procedure or surgery | Actual spinal manipulation |
| Sham spinal manipulative therapyParticipants 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 | Sham spinal manipulation |
Primary outcome
Maximal force
Time frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
Peak force registered during an isometric maximal voluntary contraction of the knee extensors.
Voluntary activation
Time frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
Electromyographic activity of the vastus lateralis muscle registered during an isometric maximal voluntary contraction of the knee extensors.
Peak power
Time frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
Peak power registered during a 30-second Wingate anaerobic cycling test
Mean power
Time frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure)
Mean power registered during a 30-second Wingate anaerobic cycling test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 30325889Valenzuela 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro de la Villa, MD, PhD study director
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulative therapy in people with Manual Therapies, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal force (time frame: On the control session and on the intervention session (immediately after the sham or actual SMT procedure)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.