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Trial record 1 of 1 for:    NCT02550132
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The Role of the Rate of Force Application in Responses to Spinal Manipulation Therapy

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ClinicalTrials.gov Identifier: NCT02550132
Recruitment Status : Completed
First Posted : September 15, 2015
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
Fondation Chiropratique du Québec
Information provided by (Responsible Party):
Martin Descarreaux, Université du Québec à Trois-Rivières

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
Spinal Manipulation Procedure: Spinal manipulation Device: Apparatus used to deliver spinal manipulations Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550132


Sponsors and Collaborators
Université du Québec à Trois-Rivières
Fondation Chiropratique du Québec
Investigators
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Principal Investigator: Martin Descarreaux, DC, PhD Université du Québec à Trois-Rivières
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: September 15, 2015    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: January 2016
Keywords provided by Martin Descarreaux, Université du Québec à Trois-Rivières:
electromyography
biomechanical phenomena
dose-response relationship
musculoskeletal manipulations
spinal manipulation