NCT02550132

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 5, 2016

Completed
Last Updated

February 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

September 8, 2015

Results QC Date

December 2, 2015

Last Update Submit

January 6, 2016

Conditions

Keywords

electromyographybiomechanical phenomenadose-response relationshipmusculoskeletal manipulationsspinal manipulation

Outcome Measures

Primary Outcomes (28)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Procedure: Spinal manipulationDevice: Apparatus used to deliver spinal manipulations

Interventions

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.

Also known as: Manual therapy
Participants

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

Participants

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult

You may not qualify if:

  • Thoracic or lumbar pain
  • History of back trauma or surgery
  • Severe osteoarthritis
  • Inflammatory arthritis
  • Vascular conditions
  • Contraindication to the use of SMT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Manipulation, SpinalMusculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationComplementary Therapies

Results Point of Contact

Title
Dr Martin Descarreaux DC, PhD
Organization
Université du Québec à Trois-Rivières

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Martin Descarreaux DC, PhD

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 15, 2015

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 5, 2016

Results First Posted

February 5, 2016

Record last verified: 2016-01