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Completed

NCT Number: NCT02550132

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

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.

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Key information

Conditions

Spinal Manipulation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal manipulation

Procedure

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

Apparatus used to deliver spinal manipulations

Device

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Collaborators

  • Fondation Chiropratique du Québec

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2015
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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