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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02550132
Other study ID # UQTR-2013-SMTrate
Secondary ID
Status Completed
Phase N/A
First received September 8, 2015
Last updated January 6, 2016
Start date June 2013
Est. completion date June 2014

Study information

Verified date January 2016
Source Université du Québec à Trois-Rivières
Contact n/a
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
Spinal manipulation
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.
Device:
Apparatus used to deliver spinal manipulations
An apparatus using a servo-controlled linear actuator motor (Linear Motor Series P01-48x360, LinMot Inc., Switzerland) will be used to deliver spinal manipulations.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Université du Québec à Trois-Rivières Fondation Chiropratique du Québec

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary 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. During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset No
Primary Vertebral Displacement of the Sixth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Seventh Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Eighth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Sixth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Seventh Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Eighth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Sixth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Seventh Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Eighth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Sixth Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Seventh Thoracic Vertebra 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 No
Primary Vertebral Displacement of the Eighth Thoracic Vertebra 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 No
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