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

Sponsor
Université du Québec à Trois-Rivières (Other)
Overall Status
Completed
CT.gov ID
NCT02550132
Collaborator
Fondation Chiropratique du Québec (Other)
25
1
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spinal manipulation
  • Device: Apparatus used to deliver spinal manipulations
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neuromechanical Response to Spinal Manipulation Therapy: Effects of a Constant Rate of Force Application
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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.

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.

    Outcome Measures

    Primary Outcome Measures

    1. Left T6 Normalized Root Mean Square (RMS) Value [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.

    2. Left T8 Normalized Root Mean Square (RMS) Value [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.

    3. Right T6 Normalized Root Mean Square (RMS) Value [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.

    4. Right T8 Normalized Root Mean Square (RMS) Value [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.

    5. Left T6 Normalized Root Mean Square (RMS) Value [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.

    6. Left T8 Normalized Root Mean Square (RMS) Value [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.

    7. Right T6 Normalized Root Mean Square (RMS) Value [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.

    8. Right T8 Normalized Root Mean Square (RMS) Value [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.

    9. Left T6 Normalized Root Mean Square (RMS) Value [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.

    10. Left T8 Normalized Root Mean Square (RMS) Value [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.

    11. Right T6 Normalized Root Mean Square (RMS) Value [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.

    12. Right T8 Normalized Root Mean Square (RMS) Value [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.

    13. Left T6 Normalized Root Mean Square (RMS) Value [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.

    14. Left T8 Normalized Root Mean Square (RMS) Value [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.

    15. Right T6 Normalized Root Mean Square (RMS) Value [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.

    16. Right T8 Normalized Root Mean Square (RMS) Value [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.

    17. Vertebral Displacement of the Sixth Thoracic Vertebra [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

    18. Vertebral Displacement of the Seventh Thoracic Vertebra [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

    19. Vertebral Displacement of the Eighth Thoracic Vertebra [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

    20. Vertebral Displacement of the Sixth Thoracic Vertebra [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

    21. Vertebral Displacement of the Seventh Thoracic Vertebra [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

    22. Vertebral Displacement of the Eighth Thoracic Vertebra [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

    23. Vertebral Displacement of the Sixth Thoracic Vertebra [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

    24. Vertebral Displacement of the Seventh Thoracic Vertebra [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

    25. Vertebral Displacement of the Eighth Thoracic Vertebra [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

    26. Vertebral Displacement of the Sixth Thoracic Vertebra [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

    27. Vertebral Displacement of the Seventh Thoracic Vertebra [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

    28. Vertebral Displacement of the Eighth Thoracic Vertebra [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Université du Québec à Trois-Rivières
    • Fondation Chiropratique du Québec

    Investigators

    • Principal Investigator: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martin Descarreaux, Dr Martin Descarreaux DC, PhD, Université du Québec à Trois-Rivières
    ClinicalTrials.gov Identifier:
    NCT02550132
    Other Study ID Numbers:
    • UQTR-2013-SMTrate
    First Posted:
    Sep 15, 2015
    Last Update Posted:
    Feb 5, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Martin Descarreaux, Dr Martin Descarreaux DC, PhD, Université du Québec à Trois-Rivières

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Participants
    Arm/Group Description 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.
    Period Title: Overall Study
    STARTED 25
    COMPLETED 25
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Participants
    Arm/Group Description 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.
    Overall Participants 25
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    24.76
    (3.8)
    Sex: Female, Male (Count of Participants)
    Female
    10
    40%
    Male
    15
    60%
    Region of Enrollment (participants) [Number]
    Canada
    25
    100%

    Outcome Measures

    1. Primary Outcome
    Title Left T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.72
    (0.68)
    2. Primary Outcome
    Title Left T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    2.83
    (0.30)
    3. Primary Outcome
    Title Right T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.03
    (0.35)
    4. Primary Outcome
    Title Right T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.51
    (0.84)
    5. Primary Outcome
    Title Left T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    4.75
    (0.76)
    6. Primary Outcome
    Title Left T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    4.12
    (0.50)
    7. Primary Outcome
    Title Right T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.13
    (0.33)
    8. Primary Outcome
    Title Right T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.46
    (0.41)
    9. Primary Outcome
    Title Left T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    4.92
    (0.91)
    10. Primary Outcome
    Title Left T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    4.03
    (0.52)
    11. Primary Outcome
    Title Right T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.40
    (0.40)
    12. Primary Outcome
    Title Right T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.57
    (0.55)
    13. Primary Outcome
    Title Left T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    4.17
    (0.53)
    14. Primary Outcome
    Title Left T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    4.80
    (0.88)
    15. Primary Outcome
    Title Right T6 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.87
    (0.64)
    16. Primary Outcome
    Title Right T8 Normalized Root Mean Square (RMS) Value
    Description Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [ratio]
    3.79
    (0.49)
    17. Primary Outcome
    Title Vertebral Displacement of the Sixth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    0.81
    (0.04)
    18. Primary Outcome
    Title Vertebral Displacement of the Seventh Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.01
    (0.03)
    19. Primary Outcome
    Title Vertebral Displacement of the Eighth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    0.76
    (0.04)
    20. Primary Outcome
    Title Vertebral Displacement of the Sixth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.18
    (0.07)
    21. Primary Outcome
    Title Vertebral Displacement of the Seventh Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.32
    (0.06)
    22. Primary Outcome
    Title Vertebral Displacement of the Eighth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.10
    (0.05)
    23. Primary Outcome
    Title Vertebral Displacement of the Sixth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.48
    (0.06)
    24. Primary Outcome
    Title Vertebral Displacement of the Seventh Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.69
    (0.05)
    25. Primary Outcome
    Title Vertebral Displacement of the Eighth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.40
    (0.05)
    26. Primary Outcome
    Title Vertebral Displacement of the Sixth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.74
    (0.09)
    27. Primary Outcome
    Title Vertebral Displacement of the Seventh Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.40
    (0.08)
    28. Primary Outcome
    Title Vertebral Displacement of the Eighth Thoracic Vertebra
    Description Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter
    Time Frame During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Participants
    Arm/Group Description 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.
    Measure Participants 25
    Mean (Standard Error) [cm]
    1.70
    (0.07)

    Adverse Events

    Time Frame Adverse event were collected during the 45 min experimental session
    Adverse Event Reporting Description Participants were invited to express their pain or discomfort during the experimental session.
    Arm/Group Title Participants
    Arm/Group Description 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.
    All Cause Mortality
    Participants
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Participants
    Affected / at Risk (%) # Events
    Total 0/25 (0%)
    Other (Not Including Serious) Adverse Events
    Participants
    Affected / at Risk (%) # Events
    Total 0/25 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr Martin Descarreaux DC, PhD
    Organization Université du Québec à Trois-Rivières
    Phone 18193765011 ext 3791
    Email martin.descarreaux@uqtr.ca
    Responsible Party:
    Martin Descarreaux, Dr Martin Descarreaux DC, PhD, Université du Québec à Trois-Rivières
    ClinicalTrials.gov Identifier:
    NCT02550132
    Other Study ID Numbers:
    • UQTR-2013-SMTrate
    First Posted:
    Sep 15, 2015
    Last Update Posted:
    Feb 5, 2016
    Last Verified:
    Jan 1, 2016