Manipulation, SpinalNCT03273868
The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity
A study testing High velocity low amplitude manipulation in people with Manipulation, Spinal, run by Institut Franco Europeen de Chiropratique at 1 site in France.
Trial summary
This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds. It is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Manipulation, Spinal
- What is being tested?
- High velocity low amplitude manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2017to 30 Oct 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First-year chiropractic student at IFEC
- Volunteer
- Healthy (no pain, no disease)
Who cannot join
- Counter indications to spinal manipulation
- Drugs intakes (pain killers or beta-blockers)
- Food, Caffeine and tobacco intakes during the previous hour
- Alcohol intake and performance of strenuous physical activity the day of the experimentation
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Franco Européen de Chiropraxie
Ivry-sur-Seine, Val De Marne, 94220
About this study
Official title: The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial
This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds.
It is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out period.
Read the detailed description
Several systematic reviews have shown that spinal manipulations may have an immediate effect on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).
It is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.
The primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.
The secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.
Cardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities
Sensitivity to experimentally-induced pain is measured using pressure pain threshold.
- Conditions
- Manipulation, Spinal
- Being tested
- High velocity low amplitude manipulation, Sham manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High velocity low amplitude manipulationOther
The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.
Sham manipulationOther
The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.
| Study group | Role | What they receive |
|---|---|---|
| High velocity low amplitude manipulation | Experimental | Not described Receives: Other: High velocity low amplitude manipulation |
| Sham manipulation | Sham comparator | Not described Receives: Other: Sham manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Frequency and Time-domain analyses of HRV from 5-minutes ECG recording
Measured: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Local (T5) and distal (L4) Pressure pain thresholds (PPT)
The mean of 3 successives PPT in kilopascal
Measured: Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes
Secondary outcomes (1)
Systolic blood pressure variability
Frequency analysis in the low frequency band of systolic blood pressure variability from 5-minutes recording
Measured: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start11 Sep 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
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 Manipulation, SpinalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Franco Europeen de Chiropratique
- Sponsor type
- University, hospital or other
- Collaborators
- French chiropractic research fund
- Responsible party
- Principal investigator, Mathieu Picchiottino, Institut Franco Europeen de Chiropratique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273868
- Sponsor's protocol ID
- Protocole IFEC 2017-01
- Status last verified
- Mar 2019
- First submitted
- 9 Aug 2017
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Picchiottino M, Honore M, Leboeuf-Yde C, Gagey O, Cottin F, Hallman DM. The effect of a single spinal manipulation on cardiovascular autonomic activity and the relationship to pressure pain threshold: a randomized, cross-over, sham-controlled trial. Chiropr Man Therap. 2020 Jan 20;28(1):7. doi: 10.1186/s12998-019-0293-4. eCollection 2020.
PubMed 31988711
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03273868
- Acronym / sponsor ID
- Protocole IFEC 2017-01
- Conditions
- Manipulation, Spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Institut Franco Europeen de ChiropratiqueUniversity, hospital or other
- Collaborators
- French chiropractic research fund
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 6 Sep 2017 (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.
This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds.
It is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out period.
Detailed description
Several systematic reviews have shown that spinal manipulations may have an immediate effect on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).
It is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.
The primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.
The secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.
Cardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities
Sensitivity to experimentally-induced pain is measured using pressure pain threshold.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High velocity low amplitude manipulation | Experimental | Other: High velocity low amplitude manipulation |
| Sham manipulation | Sham comparator | Other: Sham manipulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- First-year chiropractic student at IFEC
- Volunteer
- Healthy (no pain, no disease)
Key exclusion criteria (4 listed)
- Counter indications to spinal manipulation
- Drugs intakes (pain killers or beta-blockers)
- Food, Caffeine and tobacco intakes during the previous hour
- Alcohol intake and performance of strenuous physical activity the day of the experimentation
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 |
|---|---|---|
| High velocity low amplitude manipulationThe researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust. | Other | High velocity low amplitude manipulation |
| Sham manipulationThe researcher manually applies a preload force on the right scapula followed by a single lateral thrust. | Other | Sham manipulation |
Primary outcome
Heart rate variability (HRV)
Time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Frequency and Time-domain analyses of HRV from 5-minutes ECG recording
Local (T5) and distal (L4) Pressure pain thresholds (PPT)
Time frame: Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes
The mean of 3 successives PPT in kilopascal
1 secondary outcome
Systolic blood pressure variability
Time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 31988711Picchiottino M, Honore M, Leboeuf-Yde C, Gagey O, Cottin F, Hallman DM. The effect of a single spinal manipulation on cardiovascular autonomic activity and the relationship to pressure pain threshold: a randomized, cross-over, sham-controlled trial. Chiropr Man Therap. 2020 Jan 20;28(1):7. doi: 10.1186/s12998-019-0293-4. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High velocity low amplitude manipulation in people with Manipulation, Spinal, run by Institut Franco Europeen de Chiropratique at 1 site in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2019. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate variability (HRV) (time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes). The study lists 2 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 NCT03273868, 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 5 Mar 2019.