- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02550132
The Role of the Rate of Force Application in Responses to Spinal Manipulation Therapy
January 6, 2016 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult
Exclusion Criteria:
- Thoracic or lumbar pain
- History of back trauma or surgery
- Severe osteoarthritis
- Inflammatory arthritis
- Vascular conditions
- Contraindication to the use of SMT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
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.
|
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.
Other Names:
An apparatus using a servo-controlled linear actuator motor (Linear Motor Series P01-48x360, LinMot Inc., Switzerland) will be used to deliver spinal manipulations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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.
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
|
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
|
During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 8, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 15, 2015
Study Record Updates
Last Update Posted (Estimate)
February 5, 2016
Last Update Submitted That Met QC Criteria
January 6, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UQTR-2013-SMTrate
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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