The Role of the Rate of Force Application in Responses to Spinal Manipulation Therapy

Spinal Manipulation Clinical Trial

Official title:

Neuromechanical Response to Spinal Manipulation Therapy: Effects of a Constant Rate of Force Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550132
• Other study ID #: UQTR-2013-SMTrate
• 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

• Spinal Manipulation

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