Spinal ManipulationNCT02550132
The Role of the Rate of Force Application in Responses to Spinal Manipulation Therapy
A study testing Spinal manipulation and Apparatus used to deliver spinal manipulations in people with Spinal Manipulation, run by Université du Québec à Trois-Rivières.
Trial summary
The objective of the present study is to determine if spinal manipulations with a constant rate of force application but with different peak force and time to peak force lead to similar responses in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Manipulation
- What is being tested?
- Spinal manipulation and Apparatus used to deliver spinal manipulations
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult
Who cannot join
- Thoracic or lumbar pain
- History of back trauma or surgery
- Severe osteoarthritis
- Inflammatory arthritis
- Vascular conditions
- Contraindication to the use of SMT
About this study
Official title: Neuromechanical Response to Spinal Manipulation Therapy: Effects of a Constant Rate of Force Application
The objective of the present study is to determine if spinal manipulations with a constant rate of force application but with different peak force and time to peak force lead to similar responses in healthy adults.
Read the detailed description
Although there are indirect evidences that the rate of force application modulates neuromuscular responses to spinal manipulation therapy (SMT) through peak force or thrust duration modulations, such an assumption remains to be confirmed. Therefore, the objective of the present study was to determine if different SMT force-time profiles where a constant rate of force application would be maintained (through the modulation of the peak force and the time to peak force) lead to similar neuromechanical responses. Based on the available data relative to the effect of SMT biomechanical parameters modulation, it was hypothesized that neuromuscular responses would be similar across SMT force-time profiles, while vertebral displacements would increase as SMT peak force increases.
- Conditions
- Spinal Manipulation
- Being tested
- Spinal manipulation, Apparatus used to deliver spinal manipulations
- Keywords
- electromyography, biomechanical phenomena, dose-response relationship, musculoskeletal manipulations, spinal manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationProcedure or surgery
Also called Manual therapy
Participants will lie down during the 45-minute experimental session. Vertebral displacements (cm) and muscle response amplitude (RMS value) will be recorded through kinematic markers (on T6, T7 and T8 spinous processes) and surface electromyography electrodes (on the left and right erector spinae at T6 and T8 vertebra level). Each SMT (4 per participant) will be delivered at T7 transverse processes by an apparatus. Responses during the thrust phase (duration equal to twice the time to peak force) and after the thrust (1,5s duration) will be compared between SMTs.
Apparatus used to deliver spinal manipulationsDevice
An apparatus using a servo-controlled linear actuator motor (Linear Motor Series P01-48x360, LinMot Inc., Switzerland) will be used to deliver spinal manipulations.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N. Receives: Procedure: Spinal manipulation; Device: Apparatus used to deliver spinal manipulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Left T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T6 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Right T8 Normalized Root Mean Square (RMS) Value
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Sixth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Seventh Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Eighth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Sixth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Seventh Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Eighth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Sixth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Seventh Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Eighth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Sixth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Seventh Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Vertebral Displacement of the Eighth Thoracic Vertebra
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Measured: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Chiropratique du Québec
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, DC, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550132
- Sponsor's protocol ID
- UQTR-2013-SMTrate
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2015
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nougarou F, Page I, Loranger M, Dugas C, Descarreaux M. Neuromechanical response to spinal manipulation therapy: effects of a constant rate of force application. BMC Complement Altern Med. 2016 Jun 2;16:161. doi: 10.1186/s12906-016-1153-6.
PubMed 27249939
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromechanical Response to Spinal Manipulation Therapy: Effects of a Constant Rate of Force Application
- ClinicalTrials.gov ID
- NCT02550132
- Acronym / sponsor ID
- UQTR-2013-SMTrate
- Conditions
- Spinal Manipulation
- Keywords
- electromyography, biomechanical phenomena, dose-response relationship, musculoskeletal manipulations, spinal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Collaborators
- Fondation Chiropratique du Québec
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present study is to determine if spinal manipulations with a constant rate of force application but with different peak force and time to peak force lead to similar responses in healthy adults.
Detailed description
Although there are indirect evidences that the rate of force application modulates neuromuscular responses to spinal manipulation therapy (SMT) through peak force or thrust duration modulations, such an assumption remains to be confirmed. Therefore, the objective of the present study was to determine if different SMT force-time profiles where a constant rate of force application would be maintained (through the modulation of the peak force and the time to peak force) lead to similar neuromechanical responses. Based on the available data relative to the effect of SMT biomechanical parameters modulation, it was hypothesized that neuromuscular responses would be similar across SMT force-time profiles, while vertebral displacements would increase as SMT peak force increases.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Procedure: Spinal manipulation, Device: Apparatus used to deliver spinal manipulationsAll volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult
Key exclusion criteria (6 listed)
- Thoracic or lumbar pain
- History of back trauma or surgery
- Severe osteoarthritis
- Inflammatory arthritis
- Vascular conditions
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: Manual therapyParticipants will lie down during the 45-minute experimental session. Vertebral displacements (cm) and muscle response amplitude (RMS value) will be recorded through kinematic markers (on T6, T7 and T8 spinous processes) and surface electromyography electrodes (on the left and right erector spinae at T6 and T8 vertebra level). Each SMT (4 per participant) will be delivered at T7 transverse processes by an apparatus. Responses during the thrust phase (duration equal to twice the time to peak force) and after the thrust (1,5s duration) will be compared between SMTs. | Procedure or surgery | Participants |
| Apparatus used to deliver spinal manipulationsAn apparatus using a servo-controlled linear actuator motor (Linear Motor Series P01-48x360, LinMot Inc., Switzerland) will be used to deliver spinal manipulations. | Device | Participants |
Primary outcome
Left T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Left T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T6 Normalized Root Mean Square (RMS) Value
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Right T8 Normalized Root Mean Square (RMS) Value
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
Vertebral Displacement of the Sixth Thoracic Vertebra
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Seventh Thoracic Vertebra
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Eighth Thoracic Vertebra
Time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Sixth Thoracic Vertebra
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Seventh Thoracic Vertebra
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Eighth Thoracic Vertebra
Time frame: During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Sixth Thoracic Vertebra
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Seventh Thoracic Vertebra
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Eighth Thoracic Vertebra
Time frame: During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Sixth Thoracic Vertebra
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Seventh Thoracic Vertebra
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Vertebral Displacement of the Eighth Thoracic Vertebra
Time frame: During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27249939Nougarou F, Page I, Loranger M, Dugas C, Descarreaux M. Neuromechanical response to spinal manipulation therapy: effects of a constant rate of force application. BMC Complement Altern Med. 2016 Jun 2;16:161. doi: 10.1186/s12906-016-1153-6.
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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.
Martin Descarreaux, DC, PhD principal investigator
Université du Québec à Trois-Rivières
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulation and Apparatus used to deliver spinal manipulations in people with Spinal Manipulation, run by Université du Québec à Trois-Rivières.
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 1 inclusion and 6 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Left T6 Normalized Root Mean Square (RMS) Value (time frame: During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset). The study lists 28 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 NCT02550132, 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 Feb 2016.