Spinal ManipulationNCT03776708
Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.
A study testing Spinal manipulation in people with Spinal Manipulation, run by Institut Franco Europeen de Chiropratique at 1 site in France.
Trial summary
Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Manipulation
- What is being tested?
- Spinal manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 1 Dec 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects must be young (18-30 years old)
- asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the BOX-scale).
- Chiropractic students.
Who cannot join
- The subjects must not be reporting any spinal pain lasting more than a month
- and/or having taken painkillers 24h prior to the study.
- Contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Franco Européen de chiropraxie (iFEC)
Ivry-sur-Seine, Val De Marne, 94200
About this study
Official title: What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study
Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.
Read the detailed description
The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. Further information is needed concerning its duration and its size.
Research questions:
- What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
- What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
- What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
- What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?
- Conditions
- Spinal Manipulation
- Being tested
- Spinal manipulation, Sham procedure
- Keywords
- pressure pain threshold, asymptomatic subjects, duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationOther
Also called Spinal manipulative therapy, Adjustment
Spinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain
Sham procedureOther
Also called Placebo procedure
The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Spinal manipulation | Experimental | The spinal manipulation is located between the fifth and eighth thoracic vertebrae, on a level and a side pain-free to a light palpation. The maneuver is of high velocity and low amplitude, oriented posterior to anterior, on the transverse process area of the chosen thoracic vertebrae. Receives: Other: Spinal manipulation |
| Sham procedure | Sham comparator | The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires. Receives: Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Pressure Pain threshold
Pressure Pain Threshold is defined as the minimal pressure that provokes a pain or a discomfort. It is considered as a valid and objective method, with a good reliability.
Measured: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Oct 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal ManipulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Franco Europeen de Chiropratique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaux Honoré, Institut Franco Europeen de Chiropratique
- Investigators
- Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor, Study director, Institut Franco Européen de Chiropraxie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776708
- Sponsor's protocol ID
- InstitutFEC
- Status last verified
- Dec 2018
- First submitted
- 11 Oct 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03776708
- Acronym / sponsor ID
- InstitutFEC
- Conditions
- Spinal Manipulation
- Keywords
- pressure pain threshold, asymptomatic subjects, duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut Franco Europeen de ChiropratiqueUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 17 Dec 2018 (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.
Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.
Detailed description
The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. Further information is needed concerning its duration and its size.
Research questions:
- What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
- What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
- What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
- What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Experimental | Other: Spinal manipulationThe spinal manipulation is located between the fifth and eighth thoracic vertebrae, on a level and a side pain-free to a light palpation. The maneuver is of high velocity and low amplitude, oriented posterior to anterior, on the transverse process area of the chosen thoracic vertebrae. |
| Sham procedure | Sham comparator | Other: Sham procedureThe sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subjects must be young (18-30 years old)
- asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the BOX-scale).
- Chiropractic students.
Key exclusion criteria (3 listed)
- The subjects must not be reporting any spinal pain lasting more than a month
- and/or having taken painkillers 24h prior to the study.
- Contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).
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 manipulationAlso: Spinal manipulative therapy, AdjustmentSpinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain | Other | Spinal manipulation |
| Sham procedureAlso: Placebo procedureThe sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires | Other | Sham procedure |
Primary outcome
Change of the Pressure Pain threshold
Time frame: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.
Pressure Pain Threshold is defined as the minimal pressure that provokes a pain or a discomfort. It is considered as a valid and objective method, with a good reliability.
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 19 Dec 2018.
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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.
Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor study director
Institut Franco Européen de Chiropraxie
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 manipulation in people with Spinal Manipulation, 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 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: finished, as of the sponsor's last update on 19 Dec 2018. 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?
Change of the Pressure Pain threshold (time frame: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.