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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • Manual therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université du Québec à Trois-Rivières

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Chiropratique du Québec

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Descarreaux, DC, PhD, Universite du Quebec à Trois-Rivieres

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.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UQTR-2013-SMTrate

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